Abbott Vascular
Temecula, CA
This page shows every FDA and USDA recall linked to Abbott Vascular. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
40
Total Recalls
2010
First Recall
2022
Most Recent
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
May 19, 2022
· Device
Open, Classified
INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
Mar 11, 2022
· Device
Open, Classified
20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)
Mar 11, 2022
· Device
Open, Classified
Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01)
Plus 30 Priority Pack w/.115 RHV - RE...
Mar 11, 2022
· Device
Open, Classified
20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01)
20/30 Priority Pack w/.1...
Mar 11, 2022
· Device
Open, Classified
20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
Mar 11, 2022
· Device
Open, Classified
Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nominal Everolim...
Mar 25, 2020
· Device
Terminated
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM
The NC Traveler R...
Feb 14, 2020
· Device
Terminated
NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC
The NC TREK RX Coro...
Feb 14, 2020
· Device
Terminated
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM
The NC Traveler...
Feb 14, 2020
· Device
Terminated
NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC
The NC TREK RX Coro...
Feb 14, 2020
· Device
Terminated
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM
The NC Traveler...
Feb 14, 2020
· Device
Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC
The NC TREK RX Coro...
Feb 14, 2020
· Device
Terminated
NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM
The NC Traveler R...
Feb 14, 2020
· Device
Terminated
NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC
The NC TREK RX Coro...
Feb 14, 2020
· Device
Terminated
NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC
The NC TREK RX Coron...
Feb 14, 2020
· Device
Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC
The NC TREK RX Coron...
Feb 14, 2020
· Device
Terminated
NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC
The NC TREK RX Coron...
Feb 14, 2020
· Device
Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC
The NC TREK RX Coro...
Feb 14, 2020
· Device
Terminated
NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM
The NC Traveler R...
Feb 14, 2020
· Device
Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC
The NC TREK RX Coron...
Feb 14, 2020
· Device
Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC
The NC TREK RX Coro...
Feb 14, 2020
· Device
Terminated
NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC
The NC TREK RX Coro...
Feb 14, 2020
· Device
Terminated
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC
The NC TREK RX Corona...
Feb 14, 2020
· Device
Terminated
Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
May 1, 2019
· Device
Terminated
PLUS 30 PRIORITY PACK Accessory Kit
Product Usage:
Is recommended for use during vascular procedures in conju...
Jul 3, 2018
· Device
Terminated
Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia).
The Absorb BVS is a temporary scaffold indica...
Jun 1, 2017
· Device
Terminated
NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T,
1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T,
1...
May 12, 2017
· Device
Terminated
NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153...
May 12, 2017
· Device
Terminated
NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20,...
May 12, 2017
· Device
Terminated
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02.
The UDI is 08717648079467.
The GMDN is 474...
Feb 10, 2017
· Device
Terminated
MitraClip Clip Delivery System, product number MSK0101. The MitraClip System
contains the Clip Delivery System...
Mar 7, 2016
· Device
Terminated
Brand Name: RX Accunet Embolic Protection System
Common Name: RX Accunet EPS.
Part Numbers: 101649-45, 101164...
Jan 31, 2013
· Device
Terminated
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Sep 25, 2012
· Device
Terminated
Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve
Part Number : 1003330. For use in cardiac diagno...
Jul 12, 2011
· Device
Terminated
Abbott Vascular ACS .035 Torque Device
Part Number : 1003279.
For use in cardiac diagnostic or therapeuti...
Jul 12, 2011
· Device
Terminated
Guidant RAPIDO Cut-Away Guiding Catheter, 6F.
Part Numbers: 66676-201 and 667552-100.
For use in cardi...
Jul 12, 2011
· Device
Terminated
RX ACCULINK Carotid Stent System 7-10 X 40mm, Part Number: 1011344-40, Lot Number: 0072061
The RX Acculink Car...
Nov 10, 2010
· Device
Terminated
RX ACCULINK Carotid Stent System 9 X 20mm, Part Number: 1011341-20, Lot Number: 0071361
The RX Acculink Caroti...
Nov 10, 2010
· Device
Terminated
RX ACCULINK Carotid Stent System 10 X 20mm, Part Number: 1011342-20, Lot Number: 0072061
The RX Acculink Carot...
Nov 10, 2010
· Device
Terminated