Abbott Vascular
Medical device manufacturer in Temecula, CA.
50510(k) clearances
14PMA approvals
49recalls
Device types
- DQX Wire, Guide, Catheter 19
- LIT Catheter, Angioplasty, Peripheral… 7
- LOX Catheters, Transluminal Coronary… 6
- NTE Temporary Carotid Catheter For Embolic… 4
- DQY Catheter, Percutaneous 3
- FGE Stents, Drains And Dilators For The Biliary… 3
- DRA Catheter, Steerable 3
- GAW Suture, Nonabsorbable, Synthetic… 2
- QSY Hemostatic Wound Dressing Without Thrombin… 1
- DYB Introducer, Catheter 1
- DRE Dilator, Vessel, For Percutaneous… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K220634 | NC TREK NEO Coronary Dilatation CatheterLOX · Traditional | 06/30/2022SE |
| K221057 | Viatrac 14 Plus Peripheral Dilatation CatheterLIT · Special | 05/05/2022SE |
| K201834 | HI-TORQUE PROCEED Guide Wire FamilyDQX · Special | 07/30/2020SE |
| K200144 | HI-TORQUE Steelcore Bare Guide WireDQX · Traditional | 04/08/2020SE |
| K193126 | HI-TORQUE InfilTrac Guide Wire FamilyDQX · Special | 12/11/2019SE |
| K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresNTE · Traditional | 07/25/2019SE |
| K180040 | NC TREK RX Coronary Dilatation Catheter; NC TREK OTW Coronary Dilatation Catheter…LOX · Special | 08/24/2018SE |
| K173795 | HI-TORQUE TurnTrac Guide Wire FamilyDQX · Special | 01/12/2018SE |
| K172394 | Steerable Guide CatheterDRA · Special | 09/06/2017SE |
| K172073 | Hi-Torque Command 18 Guide WireDQX · Special | 08/25/2017SE |
| K161985 | Steerable Guide CatheterDRA · Special | 08/07/2016SE |
| K153086 | RX ACCUNET Embolic Protection SystemNTE · Special | 11/20/2015SE |
| K152709 | Hi-Torque BalanceDQX · Special | 10/21/2015SE |
| K152404 | Hi-Torque Command 18 Guide WireDQX · Special | 09/21/2015SE |
| K151317 | Armada 18 PTA CatheterLIT · Special | 07/06/2015SE |
| K142415 | Hi-Torque JET Guide Wire FamilyDQX · Traditional | 12/19/2014SE |
| K141782 | Hi-Torque Versaturn Guide WireDQX · Special | 08/07/2014SE |
| K141678 | Emboshield NAV6 Embolic Protection SystemNTE · Special | 07/22/2014SE |
| K123279 | Mini Trek RX Coronary Dilatation Catheter (Including 1.20 MM Size), Mini Trek Otw…LOX · Traditional | 01/30/2013SE |
| K123067 | Progress Guide Wire Family, Pilot Guide Wire FamilyDQX · Traditional | 01/29/2013SE |
| K122573 | Hi-Torque Command Guide Wire FamilyDQX · Traditional | 11/20/2012SE |
| K121352 | Armada 14XXT Pta CatheterDQY · Traditional | 08/15/2012SE |
| K121222 | Trek Otw Coronary Dilatation Catheter Mini Trek Otw Coronary Dilatation CatheterLOX · Special | 06/22/2012SE |
| K121015 | Emboshield NAV6 Embolic Protection SystemNTE · Special | 05/04/2012SE |
| K113464 | NC Trek Otw Coronary Dilatation CatheterLOX · Traditional | 03/06/2012SE |
| K111899 | Armada 35/35LL Pta CatheterLIT · Traditional | 10/03/2011SE |
| K112239 | Steerable Guide CatheterDRA · Special | 08/31/2011SE |
| K110617 | Mini Trek RX 1.20 MM Coronary Dilatation Catheter, Mini Trek Otw 1.20 MM Coronary…LOX · Traditional | 06/02/2011SE |
| K102705 | Armada 14 Pta CatheterLIT · Traditional | 12/07/2010SE |
| K101648 | Hi-Torque Winn Guide Wire FamilyDQX · Special | 07/08/2010SE |
| K101011 | Hi-Torque Balance Middleweight UniversalDQX · Special | 05/24/2010SE |
| K091825 | Hi-Torque Progress Guide Wire FamilyDQX · Traditional | 09/25/2009SE |
| K092286 | Fox SV Pta CatheterLIT · Special | 08/27/2009SE |
| K083738 | Hi-Torque Flex-T Guide Wire, Models 1012067-01, 02, 03, 04 and 05DQX · Special | 03/11/2009SE |
| K083732 | Tad and Tad II Tapered Guide WiresDQX · Special | 02/25/2009SE |
| K083713 | .035 Loc Guide Wire ExtensionDQX · Special | 02/23/2009SE |
| K083706 | Hi-Torque Versacore Guide WireDQX · Special | 02/06/2009SE |
| K081417 | Foxcross Pta CatheterLIT · Special | 06/04/2008SE |
| K080925 | Fox Plus Pta CatheterLIT · Special | 04/28/2008SE |
| K072460 | Hi-Torque Balance Middleweight Universal II Guide WireDQX · Traditional | 04/11/2008SE |
| K063481 | Modification to RX Herculink Elite Biliary Stent SystemFGE · Traditional | 09/14/2007SESU |
| K062554 | Starclose Hex-Hub DilatorDRE · Traditional | 02/06/2007SE |
| K060902 | Starclose Introducer Set Model- 1002DYB · Special | 07/07/2006SE |
| K032929 | Modification To:Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System, Models…FGE · Special | 10/22/2003SESU |
| K031331 | WZ Self-Expanding Stent Transhepatic Biliary SystemFGE · Traditional | 08/12/2003SESU |
| K021062 | Chito-SealQSY · Traditional | 08/23/2002SE |
| K014118 | Modification to Supercross CatheterDQY · Special | 01/11/2002SE |
| K013683 | Modification to: Abbott Vascular Suture Anastomosis DeviceGAW · Special | 12/06/2001SE |
| K001856 | Supercross CatheterDQY · Traditional | 03/07/2001SE |
| K001703 | Perclose Vascular Suture Delivery DeviceGAW · Traditional | 10/03/2000SE |
PMA approvals
- P150023 Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System · 07/05/2016 · 9 supplements
- P110028 Absolute Pro Vascular Self-Expanding Stent System · 02/22/2012 · 25 supplements
- P110019 Xience Skypoint Everolimus Eluting Coronary Stent System · 11/01/2011 · 133 supplements
- P110001 RX Herculink Elite Renal Stent System · 07/20/2011 · 21 supplements
- P070015 Xience and Promus Everolimus Eluting Coronary Stent Systems · 07/02/2008 · 136 supplements
- P040038 Xact Carotid Stent System · 09/06/2005 · 48 supplements
- P040012 Acculink Carotid Stent System and RX Acculink Carotid Stent System · 08/30/2004 · 64 supplements
- P020047 Multi-Link VISION/MINI/8 Coronary Stent Systems · 07/16/2003 · 74 supplements
- P020037 FX Minirail RX Percutaneous Transluminal Coronary Angioplasty (Ptca) Catheter · 06/11/2003 · 2 supplements
- P000011 Biodivysio AS PS (Phosphorylcholine)Coated Stent Delivery System · 09/29/2000 · 9 supplements
- P970020 Multi-Link Ultra/ Zeta Coronary Stent Systems · 10/02/1997 · 80 supplements
- P960043 Prostar 9 Fr. Percutaneous Vascular Surgical (PVS) System · 04/30/1997 · 130 supplements
- P890043 Simpson Coronary Atherocath(Tm) · 09/14/1990 · 32 supplements
- P850021 Amer, Ed. Labs. Ptca · 05/30/1986 · 31 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0733-2025 Class II | 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer… | 11/06/2024Open, Classified |
| Z-0732-2025 Class II | 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular…Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer… | 11/06/2024Open, Classified |
| Z-0731-2025 Class II | 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular…Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer… | 11/06/2024Open, Classified |
| Z-0730-2025 Class II | 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction…Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer… | 11/06/2024Open, Classified |
| Z-0117-2023 Class II | Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW…An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been… | 09/08/2022Open, Classified |
| Z-0116-2023 Class II | Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip…An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been… | 09/08/2022Open, Classified |
| Z-0115-2023 Class II | Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip…An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been… | 09/08/2022Open, Classified |
| Z-1095-2022 Class I | Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm…There is a potential that the proximal marker may separate from the imaging catheter | 03/30/2022Open, Classified |
| Z-0925-2022 Class II | Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority…Due to an increase in complaint trend for leaks and intermittent/loose connections. | 03/11/2022Open, Classified |
| Z-0924-2022 Class II | INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)Due to an increase in complaint trend for leaks and intermittent/loose connections. | 03/11/2022Open, Classified |
| Z-0923-2022 Class II | 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)Due to an increase in complaint trend for leaks and intermittent/loose connections. | 03/11/2022Open, Classified |
| Z-0922-2022 Class II | 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01)…Due to an increase in complaint trend for leaks and intermittent/loose connections. | 03/11/2022Open, Classified |
| Z-0921-2022 Class II | 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)Due to an increase in complaint trend for leaks and intermittent/loose connections. | 03/11/2022Open, Classified |
| Z-2370-2020 Class II | Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100…Incorrect expiration date | 03/25/2020Terminated |
| Z-1144-2020 Class I | NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X…Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 01/29/2020Terminated |
| Z-1143-2020 Class I | NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X…Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 01/29/2020Terminated |
| Z-1142-2020 Class I | NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X…Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 01/29/2020Terminated |
| Z-1141-2020 Class I | NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X…Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 01/29/2020Terminated |
| Z-1140-2020 Class I | NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X…Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 01/29/2020Terminated |
| Z-1139-2020 Class I | NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC…Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 01/29/2020Terminated |
| Z-1138-2020 Class I | NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC…Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 01/29/2020Terminated |
| Z-1137-2020 Class I | NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC…Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 01/29/2020Terminated |
| Z-1136-2020 Class I | NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC…Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 01/29/2020Terminated |
| Z-1135-2020 Class I | NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC…Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 01/29/2020Terminated |
| Z-1134-2020 Class I | NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC…Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 01/29/2020Terminated |
| Z-1133-2020 Class I | NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC…Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 01/29/2020Terminated |
| Z-1132-2020 Class I | NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC…Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 01/29/2020Terminated |
| Z-1131-2020 Class I | NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC…Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 01/29/2020Terminated |
| Z-1130-2020 Class I | NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC…Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 01/29/2020Terminated |
| Z-1129-2020 Class I | NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC…Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 01/29/2020Terminated |
| Z-1128-2020 Class I | NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC…Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 01/29/2020Terminated |
| Z-1687-2019 Class II | Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR…Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional… | 05/01/2019Terminated |
| Z-0960-2019 Class II | PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during…Incorrect expiration being entered for one lot. | 07/03/2018Terminated |
| Z-2151-2017 Class I | Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a…Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System due to… | 04/26/2017Terminated |
| Z-2039-2017 Class I | NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T…Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can… | 03/22/2017Terminated |
| Z-2038-2017 Class I | NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15…Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can… | 03/22/2017Terminated |
| Z-2037-2017 Class I | NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12…Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can… | 03/22/2017Terminated |
| Z-1202-2017 Class II | StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is…Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or… | 02/10/2017Terminated |
| Z-0911-2016 Class I | MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains…Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the… | 02/04/2016Terminated |
| Z-0558-2014 Class II | HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM…Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small number of… | 11/25/2013Terminated |
| Z-2450-2012 Class II | Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions…Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that… | 08/20/2012Terminated |
| Z-0757-2013 Class II | Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part…The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet… | 11/30/2011Terminated |
| Z-2793-2011 | Guidant RAPIDO Cut-Away Guiding Catheter, 6F. Part Numbers: 66676-201 and 667552-100.…Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO)… | 01/07/2011Terminated |
| Z-2792-2011 | Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number : 1003330. For…Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO)… | 01/07/2011Terminated |
| Z-2791-2011 | Abbott Vascular ACS .035 Torque Device Part Number : 1003279. For use in cardiac…Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO)… | 01/07/2011Terminated |
| Z-0339-2011 | RX ACCULINK Carotid Stent System 7-10 X 40mm, Part Number: 1011344-40, Lot Number:…The recall was initiated because Abbott vascular has discovered through internal testing that the affected… | 09/10/2010Terminated |
| Z-0338-2011 | RX ACCULINK Carotid Stent System 10 X 20mm, Part Number: 1011342-20, Lot Number: 0072061…The recall was initiated because Abbott vascular has discovered through internal testing that the affected… | 09/10/2010Terminated |
| Z-0337-2011 | RX ACCULINK Carotid Stent System 9 X 20mm, Part Number: 1011341-20, Lot Number: 0071361…The recall was initiated because Abbott vascular has discovered through internal testing that the affected… | 09/10/2010Terminated |
| Z-0575-2007 | StarClose Vascular Closure System (Clip Applier & Exchange System), Catalog Number:…Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will… | 01/31/2007Terminated |