Abbott Vascular

Complete recall history across all FDA and CPSC categories — 37 total recalls

Abbott Vascular appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (37)

FDA medical device enforcement actions by Abbott Vascular

Date Product Reason Class
Sep 8, 2022 Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G... An increase in clip locking malfunctions, Establish Final Arm Angle and Clip ... Class II
Sep 8, 2022 Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip N... An increase in clip locking malfunctions, Establish Final Arm Angle and Clip ... Class II
Sep 8, 2022 Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G... An increase in clip locking malfunctions, Establish Final Arm Angle and Clip ... Class II
Mar 30, 2022 Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, ... There is a potential that the proximal marker may separate from the imaging c... Class I
Mar 11, 2022 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 connec... Class II
Mar 11, 2022 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019... Due to an increase in complaint trend for leaks and intermittent/loose connec... Class II
Mar 11, 2022 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01) Due to an increase in complaint trend for leaks and intermittent/loose connec... Class II
Mar 11, 2022 INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01) Due to an increase in complaint trend for leaks and intermittent/loose connec... Class II
Mar 11, 2022 Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Pl... Due to an increase in complaint trend for leaks and intermittent/loose connec... Class II
Mar 25, 2020 Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStr... Incorrect expiration date Class II
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate ... Class I
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 ... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate ... Class I
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate ... Class I
Jan 29, 2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate ... Class I
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate ... Class I
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate ... Class I
Jan 29, 2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate ... Class I
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate ... Class I
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate ... Class I
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate ... Class I
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate ... Class I
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate ... Class I
Jan 29, 2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate ... Class I
Jan 29, 2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate ... Class I
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate ... Class I
Jan 29, 2020 NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate ... Class I
Jan 29, 2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler... Coronary Dilatation Catheters may exhibit difficulty or inability to deflate ... Class I
May 1, 2019 Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601... Reports of implantable mitral valve repair system clips unexpectedly opening ... Class II
Jul 3, 2018 PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use... Incorrect expiration being entered for one lot. Class II
Apr 26, 2017 Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb ... Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular S... Class I
Mar 22, 2017 NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 101244... Products from the identified lots may exhibit difficulty in removing the prot... Class I
Mar 22, 2017 NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15... Products from the identified lots may exhibit difficulty in removing the prot... Class I
Mar 22, 2017 NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 101... Products from the identified lots may exhibit difficulty in removing the prot... Class I
Feb 10, 2017 StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI... Abbott Vascular is recalling the StarClose SE Vascular Closure System because... Class II
Feb 4, 2016 MitraClip Clip Delivery System, product number MSK0101. The MitraClip System ... Abbott Vascular has recently received reports of cases on Clip Delivery Syste... Class I
Aug 20, 2012 Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation ... Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters bec... Class II
Nov 30, 2011 Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS... The recall was initiated because Abbot Vascular has discovered that the ident... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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