Home / Brands / Abbott Vascular
Abbott Vascular Recalls
42 recalls on record · October 3, 2012 to January 1, 2025 · Medical Devices
Recalls by year
12
13
14
16
17
19
20
22
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 1, 2025Medical DevicesFDA
Abbott Vascular Inc recalls 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.
Hazard: Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
January 1, 2025Medical DevicesFDA
Abbott Vascular Inc recalls 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.
Hazard: Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
January 1, 2025Medical DevicesFDA
Abbott Vascular Inc recalls 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interven
Hazard: Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
January 1, 2025Medical DevicesFDA
Abbott Vascular Inc recalls 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such
Hazard: Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
October 26, 2022Medical DevicesFDA
Abbott Vascular recalls Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW,
Hazard: An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.
October 26, 2022Medical DevicesFDA
Abbott Vascular recalls Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, Mi
Hazard: An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.
October 26, 2022Medical DevicesFDA
Abbott Vascular recalls Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, M
Hazard: An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.
May 25, 2022Medical DevicesFDA
Abbott Vascular recalls Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
Hazard: There is a potential that the proximal marker may separate from the imaging catheter
April 20, 2022Medical DevicesFDA
Abbott Vascular recalls Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 100018
Hazard: Due to an increase in complaint trend for leaks and intermittent/loose connections.
April 20, 2022Medical DevicesFDA
Abbott Vascular recalls INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
Hazard: Due to an increase in complaint trend for leaks and intermittent/loose connections.
April 20, 2022Medical DevicesFDA
Abbott Vascular recalls 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)
Hazard: Due to an increase in complaint trend for leaks and intermittent/loose connections.
April 20, 2022Medical DevicesFDA
Abbott Vascular recalls 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV -
Hazard: Due to an increase in complaint trend for leaks and intermittent/loose connections.
April 20, 2022Medical DevicesFDA
Abbott Vascular recalls 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
Hazard: Due to an increase in complaint trend for leaks and intermittent/loose connections.
June 24, 2020Medical DevicesFDA
Abbott Vascular recalls Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Conte
Hazard: Incorrect expiration date
February 26, 2020Medical DevicesFDA
Abbott Vascular recalls NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Corona
Hazard: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
February 26, 2020Medical DevicesFDA
Abbott Vascular recalls NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Corona
Hazard: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
February 26, 2020Medical DevicesFDA
Abbott Vascular recalls NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coron
Hazard: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
February 26, 2020Medical DevicesFDA
Abbott Vascular recalls NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM The NC Traveler RX Coron
Hazard: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
February 26, 2020Medical DevicesFDA
Abbott Vascular recalls NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Corona
Hazard: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
February 26, 2020Medical DevicesFDA
Abbott Vascular recalls NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC The NC TREK RX Coronary Dil
Hazard: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
February 26, 2020Medical DevicesFDA
Abbott Vascular recalls NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC The NC TREK RX Coronary Dila
Hazard: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
February 26, 2020Medical DevicesFDA
Abbott Vascular recalls NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC The NC TREK RX Coronary Dil
Hazard: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
February 26, 2020Medical DevicesFDA
Abbott Vascular recalls NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dila
Hazard: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
February 26, 2020Medical DevicesFDA
Abbott Vascular recalls NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC The NC TREK RX Coronary Dil
Hazard: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
February 26, 2020Medical DevicesFDA
Abbott Vascular recalls NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC TREK RX Coronary Dil
Hazard: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
February 26, 2020Medical DevicesFDA
Abbott Vascular recalls NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilat
Hazard: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
February 26, 2020Medical DevicesFDA
Abbott Vascular recalls NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dila
Hazard: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
February 26, 2020Medical DevicesFDA
Abbott Vascular recalls NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC The NC TREK RX Coronary Dil
Hazard: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
February 26, 2020Medical DevicesFDA
Abbott Vascular recalls NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC TREK RX Coronary Dil
Hazard: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
February 26, 2020Medical DevicesFDA
Abbott Vascular recalls NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC TREK RX Coronary Dil
Hazard: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.