Catheter, Embolectomy
FDA product code DXE · Class II (moderate risk) · 21 CFR 870.5150 · Cardiovascular
74510(k) clearances
0PMA approvals
48recalls
Manufacturers
- Edwards Lifesciences, LLC 6
- Shiley, Inc. 5
- Lucas Medical, Inc. 4
- Cathlab Corp. 4
- Applied Medical Resources Corp 4
- Ideas For Medicine, Inc. 4
- Vascutech, Inc. 4
- Cook, Inc. 3
- Atrium Medical Corporation 3
- J-Lloyd Medical, Inc. 3
- Hotspur Technologies 2
- Uresil Corp. 2
- Applied Vascular Devices, Inc. 2
- Microvena Corp. 2
- Baxter Healthcare Corp 2
- Ideal Medical, Inc. 2
- Nova Medical Specialties 1
- Mivi Neurovascular, Inc. 1
- Deseret Medical, Inc. 1
- Extracorporeal Medical Specialities, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240078 | Fogarty Thru-Lumen Embolectomy CatheterDXE · Traditional | Edwards Lifesciences, LLC | 08/28/2024SE |
| K241330 | Fogarty Fortis Arterial Embolectomy CatheterDXE · Traditional | Edwards Lifesciences | 07/02/2024SE |
| K233820 | Fogarty Arterial Embolectomy Catheter with Gate ValveDXE · Traditional | Edwards Lifesciences | 05/22/2024SE |
| K233819 | Fogarty Venous Thrombectomy CathetersDXE · Traditional | Edwards Lifesciences, LLC | 05/22/2024SE |
| K233619 | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersDXE · Traditional | Edwards Lifesciences | 05/20/2024SE |
| K213771 | Merlin Aspiration SystemDXE · Traditional | Mivi Neurovascular, Inc. | 01/27/2022SE |
| K202049 | Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterDXE · Special | Applied Medical Resources Corporation | 09/07/2021SE |
| K193379 | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon ProbeDXE · Traditional | Edwards Lifesciences, LLC | 06/12/2020SE |
| K163031 | Bunegin-Albin Air Aspiration SetDXE · Traditional | Cook Incorporated | 07/27/2017SE |
| K163353 | Needle's Eye Snare Retrieval Set - 54cmDXE · Special | Cook Incorporated | 07/11/2017SE |
| K152335 | Export Advance Aspiration CatheterDXE · Special | Medtronic, Inc. | 09/18/2015SE |
| K100842 | Pta-Plus Pta Balloon Cather 5 MM X 4CM, Pta-Plus Pta Balloon Catheter 6MM X 4CMDXE · Traditional | Hotspur Technologies | 07/12/2010SE |
| K100840 | Embo Plus Embolectomy CatheterDXE · Traditional | Hotspur Technologies | 07/12/2010SE |
| K081573 | Medtronic Export Ap CatheterDXE · Special | Medtronic Vascular | 06/27/2008SE |
| K022145 | Over the Wire Embolectomy Catheter, Model 2302DXE · Traditional | LeMaitre Vascular, Inc. | 01/14/2003SE |
| K020634 | Modification to Atrium Medical Corporation Clearway PTFE Balloon CatheterDXE · Special | Atrium Medical Corp. | 05/08/2002SE |
| K011783 | Multi-Snare SetDXE · Traditional | Pfm Produkte Fur Die Medizin AG | 01/24/2002SE |
| K002627 | Atrium Medical Corporation Clearway PTFE Balloon CatheterDXE · Traditional | Atrium Medical Corp. | 04/26/2001SE |
| K992933 | Lemaitre Irrigation CatheterDXE · Traditional | Vascutech, Inc. | 03/08/2000SE |
| K992934 | Lemaitre Venous Thrombectomy CatheterDXE · Traditional | Vascutech, Inc. | 03/01/2000SE |
| K992940 | Lemaitre Balloon Catheter with IrrigationDXE · Traditional | Vascutech, Inc. | 02/22/2000SE |
| K992368 | Lemaitre Embolectomy CatheterDXE · Traditional | Vascutech, Inc. | 12/09/1999SE |
| K973477 | Biosensors Embolectomy CatheterDXE · Traditional | Sunscope Intl., Inc. | 09/04/1998SE |
| K982141 | Arrow 5FX60CM Balloon Embolectomy Catheter, Model # EM-56025DXE · Traditional | Arrow Intl., Inc. | 08/31/1998SE |
| K971314 | Dcat Embolectomy Catheter SystemDXE · Traditional | AngioDynamics, Inc. | 03/17/1998SE |
| K972511 | Amplatz Goose Neck Snare Kit/ CatheterDXE · Traditional | Microvena Corp. | 03/06/1998SE |
| K973465 | Latis Graft Cleaning CatheterDXE · Traditional | Applied Medical Resources | 02/19/1998SE |
| K974335 | Embolectomy, Irrigation - Occlusion Balloon Catheter by J-Lloyd Medical, Inc.DXE · Traditional | J-Lloyd Medical, Inc. | 02/13/1998SE |
| K972572 | Single Lumen Embolectomy CatheterDXE · Traditional | American Biomed, Inc. | 01/13/1998SE |
| K972623 | Lmi Irrigation Catheter (Igr)DXE · Traditional | Lucas Medical, Inc. | 11/19/1997SE |
| K970657 | Lmi Thrombectomy CatheterDXE · Traditional | Lucas Medical, Inc. | 07/01/1997SE |
| K970762 | Dual Lumen Embolectomy CatheterDXE · Traditional | Applied Medical Resources | 03/28/1997SE |
| K961883 | Versa-Cath Arterial CatheterDXE · Traditional | Ideas For Medicine, Inc. | 01/13/1997SE |
| K961992 | Needle's Eye SnareDXE · Traditional | Cook Pacemaker Corp. | 12/27/1996SE |
| K961716 | Vaso-Safe Arterial Embolectomy CatheteDXE · Traditional | Ideas For Medicine, Inc. | 09/19/1996SE |
| K954760 | Lmi Arterial Embolectomy CatheterDXE · Traditional | Lucas Medical, Inc. | 04/11/1996SE |
| K955125 | Lmi Occlusion CatheterDXE · Traditional | Lucas Medical, Inc. | 03/11/1996SE |
| K950586 | Avd Intimax Thrombectomy CatheterDXE · Traditional | Applied Medical Resources | 05/15/1995SE |
| K935405 | Arterial EmbolectomyDXE · Traditional | J-Lloyd Medical, Inc. | 07/25/1994SE |
| K920823 | Welter Snare RetrieverDXE · Traditional | Cook, Inc. | 03/04/1993SE |
| K920871 | J-Lloyd Arterial Embolectomy CatheterDXE · Traditional | J-Lloyd Medical, Inc. | 02/26/1993SE |
| K914880 | Dual Balloon Embolectomy CatheterDXE · Traditional | Ideal Medical, Inc. | 03/16/1992SE |
| K910372 | Intimax Thrombectomy CatheterDXE · Traditional | Applied Vascular Devices, Inc. | 04/26/1991SE |
| K905139 | Cathlab Silicone Arterial Embolectomy CatheterDXE · Traditional | Cathlab Corp. | 02/25/1991SE |
| K902327 | Embolectomy CatheterDXE · Traditional | Clincal Instruments Corp. | 02/25/1991SE |
| K901502 | Amplatz Goose-Neck SnareDXE · Traditional | Microvena Corp. | 12/03/1990SE |
| K901627 | Arterial Embolectomy CatheterDXE · Traditional | Applied Vascular Devices, Inc. | 10/19/1990SE |
| K900311 | Arterial Embolectomy CatheterDXE · Traditional | Impra, Inc. | 07/17/1990SE |
| K901625 | Fogarty Arterial Embolectomy II CatheterDXE · Traditional | Baxter Healthcare Corp | 07/06/1990SE |
| K897184 | 3F and 4F Irrigation Embolectomy CathetersDXE · Traditional | Cathlab Corp. | 03/14/1990SE |
| K883852 | Catheter, Cardiovascular, Balloon TypeDXE · Traditional | Wb Intl., Inc. | 12/07/1989SE |
| K894681 | Revised Labeling for Arterial Embolectomy CatheterDXE · Traditional | Shiley, Inc. | 10/12/1989SE |
| K891021 | Tri-Lumen Intra Vascular Balloon CatheterDXE · Traditional | Ideal Medical, Inc. | 09/18/1989SE |
| K893680 | Silicone Bi-Lumen Irrigation Embolectomy Cath.DXE · Traditional | Cathlab Corp. | 08/01/1989SE |
| K892410 | Fogarty(R) Thru-Lumen Embolectomy CatheterDXE · Traditional | Baxter Healthcare Corp | 07/20/1989SE |
| K881455 | Embolectomy Catheter(Modified)DXE · Traditional | Cathlab Corp. | 06/15/1988SE |
| K872485 | Change of Catheter Body Material (Radio-Opaque Ny)DXE · Traditional | Ideas For Medicine, Inc. | 08/12/1987SE |
| K864330 | Shear Force GaugeDXE · Traditional | American Edwards Laboratories | 01/06/1987SE |
| K864062 | Pruitt Embolectomy/Irrigation Catheter (Modified)DXE · Traditional | Ideas For Medicine, Inc. | 01/06/1987SE |
| K864007 | Embolectomy/Thrombectomy Balloon CatheterDXE · Traditional | Uresil Corp. | 01/02/1987SE |
| K853625 | Nova Arterial Embolectomy CatheterDXE · Traditional | Nova Medical Specialties | 01/15/1986SE |
| K850015 | Polymed Lab Arterial Embolectomy CatheterDXE · Traditional | Polymed Laboratories | 06/19/1985SE |
| K840198 | Arterial Embolectomy CatheterDXE · Traditional | Shiley, Inc. | 08/03/1984SE |
| K832044 | Shiley Multipro CatheterDXE · Traditional | Shiley, Inc. | 09/29/1983SE |
| K832023 | Embolectomy CatheterDXE · Traditional | Bionomy, Inc. | 08/31/1983SE |
| K820646 | Atrac TM Multipurpose Balloon CatheterDXE · Traditional | Atrium Medical Corp. | 03/25/1982SE |
| K812640 | Ure Sil Embolectomy/Thrombectomy CathDXE · Traditional | Uresil Corp. | 10/02/1981SE |
| K801650 | Deseret Embolectomy/Thrombectomy Cath.DXE · Traditional | Deseret Medical, Inc. | 08/04/1980SE |
| K790838 | Arterial Embolectomy Catheter (Modified)DXE · Traditional | Shiley, Inc. | 06/11/1979SE |
| K780762 | Embolectomy Catheter, Extend. Shelf LifeDXE · Traditional | Shiley, Inc. | 05/26/1978SE |
| K780244 | Catheters, Arterial EmbolectomyDXE · Traditional | Extracorporeal Medical Specialities, Inc. | 04/13/1978SE |
| K770714 | Catheter, Arterial EmbolectomyDXE · Traditional | Mallinckrodt Critical Care | 04/27/1977SE |
| K770569 | Catheter, Embolectomy, UmiDXE · Traditional | Universal Medical Instrument Corp. | 04/05/1977SE |
| K761031 | Elecath Arterial Embolectomy CatheterDXE · Traditional | Electro-Catheter Corp. | 12/13/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2526-2026 Class II | Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the… | PFM Medical Inc. | 04/21/2026Open, Classified |
| Z-1750-2025 Class II | TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38…During internal product testing, it was observed that some packages to have incomplete seals (sterile… | LeMaitre Vascular, Inc. | 04/11/2025Open, Classified |
| Z-1824-2024 Class II | Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and…The guide tip can become damaged and result in the tip detaching. | LeMaitre Vascular, Inc. | 04/17/2024Open, Classified |
| Z-0238-2024 Class II | Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation… | Edwards Lifesciences, LLC | 09/07/2023Open, Classified |
| Z-0147-2023 Class II | Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FPDue to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged… | Edwards Lifesciences, LLC | 10/06/2022Open, Classified |
| Z-0146-2023 Class II | Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP…Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged… | Edwards Lifesciences, LLC | 10/06/2022Open, Classified |
| Z-0228-2023 Class II | TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single…Three lots tied by two trainees were released without performing the required pull test. If tied with… | LeMaitre Vascular, Inc. | 09/30/2022Open, Classified |
| Z-0234-2022 Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product…7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in… | Arrow International Inc | 09/20/2021Terminated |
| Z-0233-2022 Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product…7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in… | Arrow International Inc | 09/20/2021Terminated |
| Z-0232-2022 Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product…7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in… | Arrow International Inc | 09/20/2021Terminated |
| Z-0231-2022 Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product…7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in… | Arrow International Inc | 09/20/2021Terminated |
| Z-2299-2020 Class II | Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration…The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum… | Inari Medical | 03/23/2020Terminated |
| Z-1567-2020 Class I | LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84…There has been an increased trend in reports of catheters failing to deflate during use, which may… | LeMaitre Vascular, Inc. | 03/23/2020Open, Classified |
| Z-1848-2020 Class I | Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF:…The firm has received reports of tip separation during usage of the catheters, which may expose patients to… | Applied Medical Resources Corp | 10/24/2019Terminated |
| Z-1847-2020 Class I | Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R…The firm has received reports of tip separation during usage of the catheters, which may expose patients to… | Applied Medical Resources Corp | 10/24/2019Terminated |
| Z-1846-2020 Class I | Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407…The firm has received reports of tip separation during usage of the catheters, which may expose patients to… | Applied Medical Resources Corp | 10/24/2019Terminated |
| Z-3077-2017 Class II | Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The…The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm. | Edwards Lifesciences, LLC | 07/06/2017Terminated |
| Z-2911-2016 Class II | Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for…Arrow is recalling due to incorrect labeling of products. | Arrow International Inc | 07/07/2016Terminated |
| Z-1342-2016 Class I | Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch…Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports… | Boston Scientific Corporation | 03/22/2016Terminated |
| Z-0390-2016 Class II | LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | LeMaitre Vascular, Inc. | 10/21/2015Terminated |
| Z-0389-2016 Class II | LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | LeMaitre Vascular, Inc. | 10/21/2015Terminated |
| Z-0388-2016 Class II | LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | LeMaitre Vascular, Inc. | 10/21/2015Terminated |
| Z-0387-2016 Class II | LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | LeMaitre Vascular, Inc. | 10/21/2015Terminated |
| Z-0386-2016 Class II | LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | LeMaitre Vascular, Inc. | 10/21/2015Terminated |
| Z-0385-2016 Class II | LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | LeMaitre Vascular, Inc. | 10/21/2015Terminated |
| Z-0384-2016 Class II | LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | LeMaitre Vascular, Inc. | 10/21/2015Terminated |
| Z-0383-2016 Class II | LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | LeMaitre Vascular, Inc. | 10/21/2015Terminated |
| Z-0382-2016 Class II | LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | LeMaitre Vascular, Inc. | 10/21/2015Terminated |
| Z-0381-2016 Class II | LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | LeMaitre Vascular, Inc. | 10/21/2015Terminated |
| Z-0380-2016 Class II | LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | LeMaitre Vascular, Inc. | 10/21/2015Terminated |
| Z-0379-2016 Class II | LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | LeMaitre Vascular, Inc. | 10/21/2015Terminated |
| Z-0378-2016 Class II | LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34.…Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to… | LeMaitre Vascular, Inc. | 10/21/2015Terminated |
| Z-2380-2015 Class II | AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using…AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but… | Boston Scientific Corporation | 07/31/2015Terminated |
| Z-2379-2015 Class II | AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized…AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but… | Boston Scientific Corporation | 07/31/2015Terminated |
| Z-2378-2015 Class II | AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681…AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but… | Boston Scientific Corporation | 07/31/2015Terminated |
| Z-2377-2015 Class II | AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553…AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but… | Boston Scientific Corporation | 07/31/2015Terminated |
| Z-2446-2012 Class II | Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers &…Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a… | Applied Medical Resources Corp | 08/09/2012Terminated |
| Z-2946-2011 | Vascular Solutions, Pronto V4, Extraction Catheter, Sterilized using ethylene oxide, Rx…Vascular Solutions , Inc recently discovered that there was a manufacturing defect with Pronto V4 extraction… | Vascular Solutions, Inc. | 07/11/2011Terminated |
| Z-2190-2010 | Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R…Guidewire lumen may be occluded, preventing guidewire insertion into the catheter. | Spectranetics Corporation | 07/01/2010Terminated |
| Z-0547-2010 | Vascular Solutions Pronto-Short Extraction Catheter. Model 5030. The PRONTO-Short…It was found that three Pronto Short (model 5030) device lots were manufactured and labeled with an… | Vascular Solutions, Inc. | 11/20/2009Terminated |
| Z-1473-2009 | Arrow Embolectomy Catheters: 4 French, 2 Lumen x 40cm, Product Number: W01798, Single…The inflation arm tubing may separate from the stopcock adapter. | Arrow International Inc | 03/25/2009Terminated |
| Z-1472-2009 | Arrow Embolectomy Catheters: 5 French, 2 Lumen x 80cm, Product Number: W01801, Single…The inflation arm tubing may separate from the stopcock adapter. | Arrow International Inc | 03/25/2009Terminated |
| Z-1471-2009 | Arrow Embolectomy Catheters: 5 French, 2 Lumen x 40cm, Product Number: W01800, Single…The inflation arm tubing may separate from the stopcock adapter. | Arrow International Inc | 03/25/2009Terminated |
| Z-1517-2013 Class II | lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product…Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications… | Invatec Llc | 03/04/2009Terminated |
| Z-1502-2009 | Arrow OTW Percutaneous Thrombolytic Device (PTD) for fistulae and dialysis graftsLeakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | Arrow International Inc | 02/11/2009Terminated |
| Z-1131-2007 | Possis AngioJet XVG Thrombectomy Sets, Model/Order # 105042-001, Sterilized with…Mislabeling : Possis AngioJet XVG Catheter Thrombectomy Sets display incorrect information on the outer… | Possis Medical, Inc | 06/19/2007Terminated |
| Z-0992-2007 | Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile…Amplatz Goose Neck Snare Kit's catheter contained in the kit may be 4 Fr instead of the intended 6 Fr. | Ev3, Inc | 05/18/2007Terminated |
| Z-0955-2007 | Angiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Single Use Only, Sterilized with…Mislabeling: XMI (OTW) catheters were mislabeled as XMI-RX units and AVX catheters were mislabeled as… | Possis Medical, Inc | 05/01/2007Terminated |