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
May 10, 2023 ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable C... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
May 10, 2023 ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Card... There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typi... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jul 14, 2022 EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System Update to IFU provides a manual deployment workaround method to help mitigate potential harms rel... Class II Medtronic Inc.
Jun 24, 2022 Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wi... Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" ... Class II Medtronic Inc
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 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...
May 5, 2022 HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular As... Batteries for the HVAD system have a weld defect affecting internal components within the HVAD ba... Class I Medtronic Inc
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 14, 2022 HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1... The pump may have a welding defect that can lead the pump to malfunction. The issue is under inve... Class I Medtronic Inc
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...
Mar 30, 2022 Instructions for Use, Patient Manuals, and Emergency Responder Guides for Hea... Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Respo... Class II Medtronic Inc
Mar 2, 2022 Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonar... There is potential for the capsule bond to break during the procedure. Class I Medtronic Inc
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.

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.