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Browse Device Recalls

336 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 336 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 336 FDA device recalls.

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DateProductReasonClassFirm
Aug 12, 2016 Medtronic, Evera Implantable Cardioverter Defibrillators: Product Mo... 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Aug 12, 2016 Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product... 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit component... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Aug 5, 2016 CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the... Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp ... Class II Medtronic Inc.
Jun 16, 2016 Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Cat... This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding pr... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
May 26, 2016 Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink ... Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Mon... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Mar 31, 2016 Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (... A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLin... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
Feb 23, 2016 Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous E... Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ IC... Class II Medtronic Inc.
Nov 9, 2015 Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generat... Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term batte... Class II Medtronic Inc.
Sep 29, 2015 Medtronic Achieve Cables, model 990066. The sterile, single use only Electri... 64 units of Achieve Electrical Cables were shipped with a potential sterility breach. Class II Medtronic Inc.
Sep 15, 2015 Medtronic Medical Device Identification Card for SureScan pacemaker patients.... Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they ha... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Sep 1, 2015 Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performin... An issue with a USB memory component contained within a subset of CryoConsoles can result in exte... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Mar 23, 2015 Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx ... Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Periphe... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Mar 17, 2015 Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product... Possible performance issue when used with specific AA-sized (LR6) batteries. The negative termina... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Feb 23, 2015 Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath... Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end ... Class I Medtronic Inc. Cardiac Rhythm Disease Management
Apr 29, 2014 Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Gene... Events related to a pacing rate outside of the intended setting, including events of sudden incre... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... Class II Medtronic Vascular, Inc.
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm,... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... Class II Medtronic Vascular, Inc.
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm,... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... Class II Medtronic Vascular, Inc.
Jan 30, 2014 Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 7882... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-V... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP ... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-V... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jan 30, 2014 Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB... Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product famili... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Oct 7, 2013 Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Sten... A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Co... Class II Medtronic Vascular, Inc.
Jul 17, 2013 Medtronic Custom Perfusion System with Trillium BioSurface (a polymer contain... Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jul 17, 2013 Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1... Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jul 17, 2013 Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numb... Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suc... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jul 8, 2013 Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the intr... Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter ... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jun 14, 2013 Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized ... Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because ... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jun 12, 2013 Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, ... Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. ... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jun 7, 2013 Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and... Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Mar 13, 2013 Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W... Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 in... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Mar 13, 2013 Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. ... Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Sti... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Feb 19, 2013 Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopul... Potential for uncharacteristically rough metal edges to occur along the inner diameter of the met... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Nov 19, 2012 Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioA... Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that c... Class II Medtronic Inc. Cardiac Rhythm Disease Management

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.