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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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DateProductReasonClassFirm
Jun 22, 2022 Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbe... There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 22, 2022 Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization ... There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 22, 2022 Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization... There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 22, 2022 Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Nu... There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 22, 2022 Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers... There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 20, 2022 The C304-HIS device features a guide wire to access the vein, a valve to redu... The firm's internal processes identified that certain lots may have an improperly sealed barrier ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 12, 2022 Cobalt Models loaded with CareLink SmartSync Device Manager application softw... Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrill... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 12, 2022 Crome Models loaded with CareLink SmartSync Device Manager application softwa... Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrill... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jan 18, 2022 LINQ II Insertable Cardiac Monitor Devices may lose functionality due to susceptibility to moisture ingress. Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Nov 19, 2021 Instructions for Use for all model numbers of the Medtronic Abre Venous Self-... There have been reports of stent migration. Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Nov 8, 2021 Medical Device Identification Cards associated with Astra XT DR Implantable p... The back of some Medical Device Identification Cards provided to patients were printed with an er... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Nov 8, 2021 Medical Device Identification Cards associated with Sprint Quattro Lead, Prod... The back of some Medical Device Identification Cards provided to patients were printed with an er... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Oct 12, 2021 Medtronic CareLink SmartSync Device Manager application software (D00U005) us... The processing of collected episode data may fail due to a software error. Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Sep 9, 2021 C315-HIS Delivery Catheter Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inabi... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 1, 2021 Medtronic Reveal LINQ LNQ11 / PA96000 Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 14, 2021 Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO ... Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through PO... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 7, 2021 Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Card... The device may contain a manufacturing defect of a missing resistance spot weld (RSW). Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021 Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Us... A longevity estimation error may occur in the early years of device life when a unipolar pacing ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021 Programmers - Product Usage: used to treat arrhythmias related to bradycardia... A longevity estimation error may occur in the early years of device life when a unipolar pacing ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021 CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W... There is a SmartSync software issue that results in an overestimation in the displayed longevity ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021 Implantable Pulse Generators - Product Usage: used to treat arrhythmias relat... A longevity estimation error may occur in the early years of device life when a unipolar pacing ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021 CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias ... A longevity estimation error may occur in the early years of device life when a unipolar pacing ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Apr 6, 2021 CareLink SmartSync Device Manager (24970A). used to interrogate cardiac impl... There is a SmartSync software issue that results in an overestimation in the displayed longevity ... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Mar 23, 2021 VenaSeal Closure System Firm received increased number of reports that VenaSeal dispensing systems are not effectively ad... Class III Medtronic Inc.
Mar 16, 2021 Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U1608... Incorrect size printed on the device; packaging is labeled correctly. Class II Medtronic Inc.
Feb 26, 2021 Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neopla... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: ... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 26, 2021 Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging:... Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neop... Class II Medtronic Inc.
Feb 3, 2021 Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR,... A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Feb 3, 2021 Implantable cardioverter defibrillators (ICD) with cardiac resynchronization ... A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Nov 15, 2020 Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditi... Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Nov 15, 2020 Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable ca... Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Nov 15, 2020 Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual cha... Under rare circumstances, the component may be susceptible to a failure mechanism that could impa... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...

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.