Browse Device Recalls

319 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 319 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 319 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jun 21, 2018	Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with A...	Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018	Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The imp...	Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018	Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with At...	Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing th...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018	Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P mod...	Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018	Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P mod...	Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 21, 2018	Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models a...	Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI ...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 6, 2018	Single Chamber Temporary External Pacemaker, Model 53401	A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 16, 2018	Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glu...	CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and di...	Class II	Medtronic Inc.
Apr 24, 2018	Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554,...	The MiniMed Paradigm Veo insulin pump has an error that impacts the Arabic language translation.T...	Class II	Medtronic Inc.
Dec 19, 2017	Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Label...	Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri...	Class I	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017	Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Label...	Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri...	Class I	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017	Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Label...	Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri...	Class I	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017	Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the ...	Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri...	Class I	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017	Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as ...	Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri...	Class I	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017	Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. V...	Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri...	Class I	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017	Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the followi...	Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri...	Class I	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017	Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the fo...	Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri...	Class I	Medtronic Inc., Cardiac Rhythm and Heart Failur...
Nov 3, 2017	Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Inten...	Stent length on the label may not match the length of the stent itself.	Class II	Medtronic Inc.
Oct 10, 2017	Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink...	Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro so...	Class II	Medtronic Inc.
Sep 10, 2017	Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398...	Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.	Class II	Medtronic Inc.
Sep 10, 2017	Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T...	Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.	Class II	Medtronic Inc.
Sep 10, 2017	Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 36...	Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.	Class II	Medtronic Inc.
Sep 10, 2017	Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 8...	Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.	Class II	Medtronic Inc.
Sep 10, 2017	Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)	Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.	Class II	Medtronic Inc.
Jul 14, 2017	MyCareLink Patient Monitors. It is intended for used with a compatible Med...	Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failure
Jul 14, 2017	MyCareLink Smart Patient Monitors. It is intended for use with a compatibl...	Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failure
May 8, 2017	MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512,...	Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar...	Class II	Medtronic Inc.
May 8, 2017	MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.	Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar...	Class II	Medtronic Inc.
May 8, 2017	MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782,...	Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar...	Class II	Medtronic Inc.
May 8, 2017	MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550,...	Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporar...	Class II	Medtronic Inc.
Apr 12, 2017	Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Qu...	An unexpected transient mode switch behavior was detected by Medtronic during systems testing tha...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failure
Jan 31, 2017	MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and bel...	Medtronic has identified a software anomaly that can prevent the internal battery of the pump fro...	Class II	Medtronic Inc.
Dec 9, 2016	Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria M...	During internal testing conducted as part of next generation product development, it was discover...	Class II	Medtronic Inc., Cardiac Rhythm and Heart Failure
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.

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.