Bard Peripheral Vascular Inc
Medical device manufacturer in Tempe, AZ.
39510(k) clearances
6PMA approvals
232recalls
Device types
- KNW Instrument, Biopsy 8
- LIT Catheter, Angioplasty, Peripheral… 6
- DQY Catheter, Percutaneous 5
- NEU Marker, Radiographic, Implantable 3
- JCT Prosthesis, Tracheal, Expandable 2
- DSY Prosthesis, Vascular Graft, Of 6mm And… 2
- FGE Stents, Drains And Dilators For The Biliary… 2
- DTK Filter, Intravascular, Cardiovascular 2
- PNO Catheter, Percutaneous, Cutting/Scoring 2
- KCT Sterilization Wrap Containers, Trays… 1
- OZT Balloon Aortic Valvuloplasty 1
- MSD Catheter, Hemodialysis, Implanted 1
- DYB Introducer, Catheter 1
- LJT Port & Catheter, Implanted, Subcutaneous… 1
- PNG Peritoneal, Drainage Catheter For… 1
- MCW Catheter, Peripheral, Atherectomy 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Special | 08/14/2026SE |
| K260012 | UltraScore Focused Force PTA BalloonPNO · Special | 02/04/2026SE |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Traditional | 12/12/2025SE |
| K250032 | Marquee Disposable Core Biopsy Instrument and Instrument KitKNW · Special | 07/10/2025SE |
| K250219 | Dorado PTA Balloon Dilatation CatheterDQY · Traditional | 06/17/2025SE |
| K243642 | UltraCor Twirl Breast Tissue MarkerNEU · Traditional | 03/24/2025SE |
| K242757 | Rotarex Atherectomy SystemMCW · Special | 01/30/2025SE |
| K241946 | PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal…PNG · Traditional | 12/06/2024SE |
| K232737 | PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG…LJT · Special | 12/08/2023SE |
| K221440 | Liverty TIPS Access SetDYB · Traditional | 05/31/2022SE |
| K213896 | BD Trek Powered Bone Biopsy SystemKNW · Traditional | 03/30/2022SE |
| K211933 | EleVation Breast Biopsy SystemKNW · Special | 07/15/2021SE |
| K211410 | GlidePath 13F Long-Term Hemodialysis CatheterMSD · Special | 06/04/2021SESK |
| K192948 | EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast…KNW · Special | 11/07/2019SE |
| K192318 | Ultraverse 014 and 018 PTA Balloon Dilatation CathetersLIT · Traditional | 10/03/2019SE |
| K180061 | UltraCor Twirl Breast Tissue MarkerNEU · Traditional | 03/09/2018SE |
| K171953 | Bard Mission Disposable Core Biopsy InstrumentKNW · Traditional | 09/14/2017SE |
| K163420 | UltraScore Focused Force PTA BalloonPNO · Traditional | 06/14/2017SE |
| K161986 | SIDEKICK and USHER Support CathetersDQY · Special | 08/04/2016SE |
| K152510 | UltraCor Twirl Breast Tissue MarkerNEU · Traditional | 05/13/2016SE |
| K142261 | Ultraverse 035 PTA Balloon Dilatation CatheterLIT · Traditional | 09/24/2014SE |
| K133948 | Bard(R) Monopty(R) Disposable Core Biopsy Instrument, Bard(R) Max-Core(R) Disposable…KNW · Special | 02/21/2014SE |
| K133569 | True Dilatation Balloon Valvuloplasty Catheter, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X…OZT · Special | 12/20/2013SE |
| K131199 | Ultraverse RX Pta Balloon Dilatation CatheterLIT · Traditional | 05/30/2013SE |
| K120971 | Atlas Pta Balloon Dilatation CatheterLIT · Traditional | 04/19/2012SE |
| K120722 | Rival Pta Dilatation CatheterLIT · Traditional | 04/19/2012SE |
| K120660 | Conquest 40 Pta Dilatation CatheterLIT · Traditional | 03/15/2012SE |
| K103367 | Seeker Crossing Support CatheterDQY · Traditional | 12/08/2010SE |
| K063532 | Bard E Luminexx Biliary StentFGE · Traditional | 05/30/2008SESU |
| K072283 | Dorado Pta Balloon Dilatation CatheterDQY · Traditional | 09/19/2007SE |
| K062887 | Modification to G2 Filter System-Femoral Delivery Kit, Model RF-310FDTK · Special | 10/26/2006SE |
| K052578 | Bard G2 Filter System - Jugular/Subclavian Delivery Kit, Model RF-320JDTK · Special | 11/25/2005SESU |
| K052282 | Venaflo II Vascular GraftDSY · Special | 09/20/2005SE |
| K052114 | Bard Conformexx Biliary Stent with the Performaxx GripFGE · Special | 08/25/2005SESU |
| K052236 | Bard Atlas Pta Balloon Dilatation CatheterDQY · Special | 08/23/2005SE |
| K050832 | Fluency Plus Tracheobronchial Stent GraftJCT · Special | 07/07/2005SE |
| K050049 | Dynaflo Bypass GraftDSY · Special | 01/31/2005SE |
| K042062 | Peripheral Vascular Sheath Tunneler Sterilization CassetteKCT · Traditional | 09/30/2004SE |
| K031041 | Fluency Tracheobronchial Stent GraftJCT · Abbreviated | 06/19/2003SE |
PMA approvals
- P180037 Venovo Venous Stent System · 03/13/2019 · 14 supplements
- P160024 Lifestream Balloon Expandable Vascular Covered Stent · 04/24/2017 · 14 supplements
- P130029 Fluency Plus Endovascular Stent Graft · 06/17/2014 · 14 supplements
- P070014 Lifestent Flexstar & Flexstar XL Vascular Stent System · 02/13/2009 · 66 supplements
- P080007 Bard E-Luminexx Vascular Stent · 12/04/2008 · 24 supplements
- P060002 Flair Endovascular Stent Graft · 07/23/2007 · 36 supplements
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-1367-2026 Class II | Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff…Due to damage to outer tray that can potentially compromise the sterile barrier | 12/12/2025Open, Classified |
| Z-0887-2026 Class II | Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure… | 11/06/2025Open, Classified |
| Z-2638-2025 Class II | Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify…Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature… | 08/21/2025Open, Classified |
| Z-1244-2025 Class I | Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm…Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the… | 02/05/2025Open, Classified |
| Z-0467-2025 Class II | Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF:…Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on… | 09/30/2024Open, Classified |
| Z-0371-2025 Class II | The EVSRF catheter is a sterile, single-use disposable medical device for endovenous…The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and… | 09/04/2024Open, Classified |
| Z-3206-2024 Class II | BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616…Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the… | 08/02/2024Open, Classified |
| Z-3062-2024 Class II | Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with…Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop… | 07/10/2024Open, Classified |
| Z-0676-2024 Class II | BD Recanalization System, REF: BDRECANSYSTEMRecanalization systems may be in a manufacturing mode that allows the system to continuously run without the… | 11/14/2023Open, Classified |
| Z-0643-2024 Class II | Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G…The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the… | 11/08/2023Open, Classified |
| Z-0027-2024 Class II | Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument… | 08/10/2023Open, Classified |
| Z-1564-2023 Class II | Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF:…Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length… | 04/11/2023Open, Classified |
| Z-1260-2023 Class II | Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x…The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle… | 02/28/2023Open, Classified |
| Z-1051-2023 Class II | Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610…Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable). | 01/04/2023Open, Classified |
| Z-1108-2023 Class II | The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised…An increase in the reported complaint rate for inability to deploy was identified and related to poor slide… | 12/22/2022Open, Classified |
| Z-1273-2022 Class II | REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle.… | 04/22/2022Open, Classified |
| Z-0800-2022 Class II | SAFE-T PLUS ATRAUMATIC ADULT LP TRAYDue to lumbar puncture tray manometer failure mode of leaking and mating issues. | 01/20/2022Open, Classified |
| Z-0799-2022 Class II | LUMBAR PUNCTURE DRUG FREE TRAY 22GDue to lumbar puncture tray manometer failure mode of leaking and mating issues. | 01/20/2022Open, Classified |
| Z-0798-2022 Class II | ATRAUMATIC ADULT LUMBAR PUNCTURE TRAYDue to lumbar puncture tray manometer failure mode of leaking and mating issues. | 01/20/2022Open, Classified |
| Z-0797-2022 Class II | SAFE-T PLUS LUMBARPUNCTURE TRAY ADULTDue to lumbar puncture tray manometer failure mode of leaking and mating issues. | 01/20/2022Open, Classified |
| Z-0796-2022 Class II | LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRLDue to lumbar puncture tray manometer failure mode of leaking and mating issues. | 01/20/2022Open, Classified |
| Z-0795-2022 Class II | LUMBAR PUNCTURE TRAY ADULT 18G X 3.5Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | 01/20/2022Open, Classified |
| Z-0794-2022 Class II | SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULTDue to lumbar puncture tray manometer failure mode of leaking and mating issues. | 01/20/2022Open, Classified |
| Z-0793-2022 Class II | ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20GDue to lumbar puncture tray manometer failure mode of leaking and mating issues. | 01/20/2022Open, Classified |
| Z-0792-2022 Class II | LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DPDue to lumbar puncture tray manometer failure mode of leaking and mating issues. | 01/20/2022Open, Classified |
| Z-0791-2022 Class II | LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | 01/20/2022Open, Classified |
| Z-0790-2022 Class II | Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with…Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | 01/20/2022Open, Classified |
| Z-0154-2022 Class II | Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration…Due to misbranded products shipped to customers. | 08/24/2021Terminated |
| Z-0153-2022 Class II | Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11…Due to misbranded products shipped to customers. | 08/24/2021Terminated |
| Z-0002-2022 Class II | REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single…Potential for needle protector to become fully dislodge exposing infusion needle which could result in… | 07/27/2021Open, Classified |
| Z-2249-2021 Class II | TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015…Due to complaints received regarding incomplete/open packaging seals potentially causing product to… | 06/23/2021Open, Classified |
| Z-2248-2021 Class II | EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G…Due to complaints received regarding incomplete/open packaging seals potentially causing product to… | 06/23/2021Open, Classified |
| Z-2247-2021 Class II | TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition…Due to complaints received regarding incomplete/open packaging seals potentially causing product to… | 06/23/2021Open, Classified |
| Z-1552-2021 Class II | PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended…Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements. | 03/25/2021Terminated |
| Z-1551-2021 Class II | PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended…Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements. | 03/25/2021Terminated |
| Z-1550-2021 Class II | PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended…Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements. | 03/25/2021Terminated |
| Z-1289-2021 Class II | BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX…Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for… | 01/14/2021Terminated |
| Z-1899-2021 Class II | VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F…Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected… | 12/14/2020Open, Classified |
| Z-1898-2021 Class II | VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F…Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected… | 12/14/2020Open, Classified |
| Z-1897-2021 Class II | VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F…Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected… | 12/14/2020Open, Classified |
| Z-0080-2021 Class II | Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI:…Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x… | 10/01/2020Terminated |
| Z-1689-2020 Class II | Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile…Sterility compromised due to packaging pouches that may not be sealed properly | 03/17/2020Terminated |
| Z-1964-2020 Class II | BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and…The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device… | 01/15/2020Open, Classified |
| Z-1434-2020 Class II | Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged…Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was… | 01/03/2020Terminated |
| Z-1433-2020 Class II | Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged…Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was… | 01/03/2020Terminated |
| Z-1432-2020 Class II | Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually…Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was… | 01/03/2020Terminated |
| Z-1431-2020 Class II | Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged…Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was… | 01/03/2020Terminated |
| Z-0724-2020 Class II | BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy…During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy… | 10/25/2019Terminated |
| Z-1579-2020 Class II | PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-1578-2020 Class II | 1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-1577-2020 Class II | BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-1576-2020 Class II | BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-1575-2020 Class II | BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-1574-2020 Class II | 1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570; 2.…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-1573-2020 Class II | 1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-1572-2020 Class II | 1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-1571-2020 Class II | 1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-1570-2020 Class II | 1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous…Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip… | 10/01/2019Terminated |
| Z-0917-2020 Class II | Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm…The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended size 8mm X… | 08/14/2019Terminated |
| Z-2209-2020 Class II | EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16FIncorrect Peel-Apart Introducer Sheath in Kit. | 06/14/2019Terminated |
| Z-2208-2020 Class II | EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16FIncorrect Peel-Apart Introducer Sheath in Kit. | 06/14/2019Terminated |
| Z-2395-2019 Class II | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2394-2019 Class II | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2393-2019 Class II | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2392-2019 Class II | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2391-2019 Class II | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2390-2019 Class II | GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2389-2019 Class II | GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396280, 14.5F, Alphacurve…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2388-2019 Class II | GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396240, 14.5F, Alphacurve…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2387-2019 Class II | GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396190, 14.5F, Alphacurve…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2386-2019 Class II | GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2385-2019 Class II | GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2384-2019 Class II | GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2383-2019 Class II | GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2382-2019 Class II | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2381-2019 Class II | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2380-2019 Class II | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2379-2019 Class II | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2378-2019 Class II | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2377-2019 Class II | EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2376-2019 Class II | EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2375-2019 Class II | EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2374-2019 Class II | EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2373-2019 Class II | EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2372-2019 Class II | EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2371-2019 Class II | EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2370-2019 Class II | EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr.…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2369-2019 Class II | EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr.…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2368-2019 Class II | EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr.…The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking… | 05/31/2019Terminated |
| Z-2214-2019 Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples… | 05/02/2019Terminated |
| Z-2213-2019 Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples… | 05/02/2019Terminated |
| Z-2212-2019 Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples… | 05/02/2019Terminated |
| Z-2211-2019 Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples… | 05/02/2019Terminated |
| Z-2210-2019 Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples… | 05/02/2019Terminated |
| Z-2209-2019 Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples… | 05/02/2019Terminated |
| Z-1637-2020 Class II | BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile…The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at… | 04/12/2019Terminated |
| Z-0718-2020 Class II | LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X…Certain product code/lot number combinations may experience introducer sheath compatibility issues when used… | 02/18/2019Terminated |
| Z-0582-2020 Class II | PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended…Complaints received that products packaged with the incorrect introducer sheath size. | 02/14/2019Open, Classified |
| Z-2080-2019 Class II | POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit…Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack… | 06/25/2018Completed |
| Z-1803-2018 Class II | BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF…Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the… | 04/16/2018Terminated |
| Z-1802-2018 Class II | BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF…Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the… | 04/16/2018Terminated |
| Z-1773-2018 Class II | POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F…The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains… | 02/08/2018Completed |
| Z-1772-2018 Class II | POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F…The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains… | 02/08/2018Completed |
| Z-1771-2018 Class II | POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with…The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains… | 02/08/2018Completed |
| Z-1770-2018 Class II | POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with…The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains… | 02/08/2018Completed |
| Z-1769-2018 Class II | POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter…The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains… | 02/08/2018Completed |
| Z-1768-2018 Class II | POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter…The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains… | 02/08/2018Completed |
| Z-1767-2018 Class II | POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF…The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains… | 02/08/2018Completed |
| Z-1766-2018 Class II | POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF…The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains… | 02/08/2018Completed |
| Z-1765-2018 Class II | POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with…The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains… | 02/08/2018Completed |
| Z-1764-2018 Class II | POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF…The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains… | 02/08/2018Completed |
| Z-1763-2018 Class II | POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with…The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains… | 02/08/2018Completed |
| Z-1762-2018 Class II | POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter…The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains… | 02/08/2018Completed |
| Z-1761-2018 Class II | POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF…The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains… | 02/08/2018Completed |
| Z-1760-2018 Class II | POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane…The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains… | 02/08/2018Completed |
| Z-0044-2018 Class II | BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm…During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core Biopsy… | 09/22/2017Terminated |
| Z-1900-2017 Class II | MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage:…It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR… | 03/28/2017Terminated |
| Z-0970-2017 Class I | Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo…Complaints of sheath separation, kinking, and/or tip damage during use. | 12/02/2016Terminated |
| Z-0969-2017 Class I | Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage: The Halo One…Complaints of sheath separation, kinking, and/or tip damage during use. | 12/02/2016Terminated |
| Z-0968-2017 Class I | Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled…Complaints of sheath separation, kinking, and/or tip damage during use. | 12/02/2016Terminated |
| Z-2547-2016 Class II | Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product Part Number C1816B The…May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each. | 07/06/2016Terminated |
| Z-1069-2016 Class II | Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicated for use in…Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali… | 02/09/2016Terminated |
| Z-1068-2016 Class II | Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; Indicated…Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali… | 02/09/2016Terminated |
| Z-1396-2016 Class II | Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable…Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they… | 02/04/2016Terminated |
| Z-0786-2016 Class II | Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for…Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft. | 01/05/2016Terminated |
| Z-0785-2016 Class II | Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for…Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm… | 01/05/2016Terminated |
| Z-0223-2016 Class II | FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm…Bard Peripheral Vascular (BPV) is recalling the Bard Flair Endovascular Stent Graft because of the harm… | 10/19/2015Terminated |
| Z-1586-2015 Class II | BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD…The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having… | 04/09/2015Terminated |
| Z-1413-2015 Class II | Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at… | 03/23/2015Terminated |
| Z-1447-2015 Class II | Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm)…Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because… | 03/17/2015Terminated |
| Z-0737-2016 Class II | Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F.…IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to… | 03/13/2015Terminated |
| Z-2648-2014 Class II | Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037…Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at risk of… | 08/26/2014Terminated |
| Z-0007-2014 Class I | Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL…Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have… | 09/30/2013Terminated |
| Z-1533-2013 Class II | BARD PERIPHERAL VASCULAR VACCESS PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm.…Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may… | 05/28/2013Terminated |
| Z-1524-2013 Class II | BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to…Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number… | 04/16/2013Terminated |
| Z-1529-2013 Class II | USHER Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only…Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard UltraClip Dual… | 01/23/2013Terminated |
| Z-1528-2013 Class II | MICROSHEATH - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID:…Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard UltraClip Dual… | 01/23/2013Terminated |
| Z-1527-2013 Class II | BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual…Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard UltraClip Dual… | 01/23/2013Terminated |
| Z-1526-2013 Class II | BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual…Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard UltraClip Dual… | 01/23/2013Terminated |
| Z-0351-2012 | The EnCor biopsy probe, designed for use with EnCor and EnCor Enspire Vacuum Assisted…This recall was voluntarily initiated by the firm due to the product 's damaged packaging trays; cracked… | 11/03/2011Terminated |
| Z-2136-2010 | BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135720The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain… | 05/04/2010Terminated |
| Z-2135-2010 | BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135717The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain… | 05/04/2010Terminated |
| Z-2134-2010 | BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135715The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain… | 05/04/2010Terminated |
| Z-2133-2010 | BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135712The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain… | 05/04/2010Terminated |
| Z-2132-2010 | BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135620The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain… | 05/04/2010Terminated |
| Z-2131-2010 | BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135615The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain… | 05/04/2010Terminated |
| Z-2130-2010 | BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135612The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain… | 05/04/2010Terminated |
| Z-2129-2010 | BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135520The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain… | 05/04/2010Terminated |
| Z-2128-2010 | BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135517The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain… | 05/04/2010Terminated |
| Z-2127-2010 | BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135515The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain… | 05/04/2010Terminated |
| Z-2126-2010 | BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135512The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain… | 05/04/2010Terminated |
| Z-2125-2010 | BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135420The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain… | 05/04/2010Terminated |
| Z-2124-2010 | BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135417The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain… | 05/04/2010Terminated |
| Z-2123-2010 | BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135415The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain… | 05/04/2010Terminated |
| Z-2122-2010 | BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135412The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain… | 05/04/2010Terminated |
| Z-0276-2010 | Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1620. Bard Magnum…The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge… | 10/08/2009Terminated |
| Z-0275-2010 | Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1616. Bard Magnum…The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge… | 10/08/2009Terminated |
| Z-0274-2010 | Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1613. Bard Magnum…The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge… | 10/08/2009Terminated |
| Z-0273-2010 | Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1610. Bard Magnum…The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge… | 10/08/2009Terminated |
| Z-1469-2009 | Bard E LUMINEXX Biliary Stent, Size: 14mm x 80mm, Product Number: ZBM14080.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1468-2009 | Bard E LUMINEXX Biliary Stent, Size 14mm x 60mm, Product Number: ZBM14060.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1467-2009 | Bard E LUMINEXX Biliary Stent, Size: 14mm x 40mm, Product Number: ZBM14040.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1466-2009 | Bard E LUMINEXX Biliary Stent, Size: 14mm x 30mm, Product Number: ZBM14030.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1465-2009 | Bard E LUMINEXX Biliary Stent, Size: 12mm x 80mm Product Number: ZBM12080.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1464-2009 | Bard E LUMINEXX Biliary Stent, Size: 12mm x 60mm, Product Number: ZBM12060.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1463-2009 | Bard E LUMINEXX Biliary Stent, Size: 12mm x 40mm, Product Number: ZBM12040.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1462-2009 | Bard E LUMINEXX Biliary Stent, Size: 6mm x 80mm, Product Number: ZBM06080.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1461-2009 | Bard E LUMINEXX Biliary Stent, Size: 6mm x 60mm, Product Number: ZBM06060.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1460-2009 | Bard E LUMINEXX Biliary Stent, Size: 6mm x 40mm, Product Number: ZBM06040.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1459-2009 | Bard E LUMINEXX Biliary Stent, Size: 6mm x 30mm, Product Number: ZBM06030.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1458-2009 | Bard E LUMINEXX Biliary Stent,Size: 6mm x 20mm, Product Number: ZBM06020.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1457-2009 | Bard E LUMINEXX Biliary Stent, Size: 14mm x 60mm, Product Number: ZBL14060.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1456-2009 | Bard E LUMINEXX Biliary Stent, Size: 12mm x 40mm, Product Number: ZBL12040.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1455-2009 | Bard E LUMINEXX, Biliary Stent Size: 6mm x 80mm, Product Number: ZBL06080.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1454-2009 | Bard E LUMINEXX Biliary Stent, Size: 6mm x 40mm, Product Number: ZBL06040.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-1453-2009 | Bard E LUMINEXX Biliary Stent, Size: 5mm x 120mm, Product Number: ZBL05120.This action is being taken because a label for an indicated use was applied to product sizes that are not… | 12/23/2008Terminated |
| Z-0183-2009 | Bard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and VB10140.Some of the Vacora Biopsy Vacuum Assisted Biopsy Probe thumb wheels from these lots may fracture when fired… | 09/12/2008Terminated |
| Z-0085-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0084-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0083-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0082-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0081-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0080-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0079-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0078-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0077-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0076-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0075-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0074-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0073-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0072-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0071-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0070-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0069-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0068-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0067-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0066-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0065-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0064-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |
| Z-0063-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards…Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary… | 08/29/2008Terminated |