Browse Device Recalls

42 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 42 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 42 FDA device recalls.

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Date	Product	Reason	Class	Firm
Nov 6, 2024	20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular p...	Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rot...	Class II	Abbott Vascular Inc
Nov 6, 2024	20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in c...	Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rot...	Class II	Abbott Vascular Inc
Nov 6, 2024	20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascu...	Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rot...	Class II	Abbott Vascular Inc
Nov 6, 2024	20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovas...	Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rot...	Class II	Abbott Vascular Inc
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 Opening While Locked...	Class II	Abbott Vascular
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 Opening While Locked...	Class II	Abbott Vascular
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 Opening While Locked...	Class II	Abbott Vascular
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 catheter	Class I	Abbott Vascular
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 connections.	Class II	Abbott Vascular
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 connections.	Class II	Abbott Vascular
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 connections.	Class II	Abbott Vascular
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 connections.	Class II	Abbott Vascular
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 connections.	Class II	Abbott Vascular
Mar 25, 2020	Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStr...	Incorrect expiration date	Class II	Abbott Vascular
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 the balloon.	Class I	Abbott Vascular
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 the balloon.	Class I	Abbott Vascular
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 the balloon.	Class I	Abbott Vascular
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 the balloon.	Class I	Abbott Vascular
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 the balloon.	Class I	Abbott Vascular
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 the balloon.	Class I	Abbott Vascular
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 the balloon.	Class I	Abbott Vascular
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 the balloon.	Class I	Abbott Vascular
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 the balloon.	Class I	Abbott Vascular
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 the balloon.	Class I	Abbott Vascular
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 the balloon.	Class I	Abbott Vascular
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 the balloon.	Class I	Abbott Vascular
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 the balloon.	Class I	Abbott Vascular
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 the balloon.	Class I	Abbott Vascular
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 the balloon.	Class I	Abbott Vascular
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 the balloon.	Class I	Abbott Vascular
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 the balloon.	Class I	Abbott Vascular
May 1, 2019	Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601...	Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunc...	Class II	Abbott Vascular
Jul 3, 2018	PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use...	Incorrect expiration being entered for one lot.	Class II	Abbott Vascular
Apr 26, 2017	Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb ...	Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System...	Class I	Abbott Vascular
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 protective balloon sheat...	Class I	Abbott Vascular
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 protective balloon sheat...	Class I	Abbott Vascular
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 protective balloon sheat...	Class I	Abbott Vascular
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 it may exhibit diff...	Class II	Abbott Vascular
Feb 4, 2016	MitraClip Clip Delivery System, product number MSK0101. The MitraClip System ...	Abbott Vascular has recently received reports of cases on Clip Delivery System devices that conta...	Class I	Abbott Vascular
Nov 25, 2013	HT Connect Peripheral Guide Wire Part Number Description 1012587 ...	Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small nu...	Class II	Abbott Vascular, Inc.
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 because they have disco...	Class II	Abbott Vascular
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 identified lots of the RX...	Class II	Abbott Vascular

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.