Browse Device Recalls

603 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 603 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 603 FDA device recalls.

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DateProductReasonClassFirm
Dec 7, 2017 ACCOLADE EL DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ESSENTIO MRI EL DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ESSENTIO MRI SR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ALTRUA 2 SR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ESSENTIO SR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ACCOLADE MRI SR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ACCOLADE MRI DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 PROPONENT EL DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 VALITUDE CRT-P Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 PROPONENT DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ACCOLADE MRI EL DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ALTRUA 2 EL DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ESSENTIO DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 VISIONIST CRT-P Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ACCOLADE SR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ACCOLADE DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 PROPONENT SR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Nov 6, 2017 Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and ... Stent possibly unable to be fully released from the delivery system. Class II Boston Scientific Corporation
Nov 6, 2017 Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and... Stent possibly unable to be fully released from the delivery system. Class II Boston Scientific Corporation
Oct 4, 2017 VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therap... The devices have an incorrect firmware configuration. Class II Boston Scientific Corporation
Oct 4, 2017 RESONATE EL ICD DR, Model D433, Sterile. The devices have an incorrect firmware configuration. Class II Boston Scientific Corporation
Oct 4, 2017 MOMENTUM X4 CRT-D, Model G138, Sterile. The devices have an incorrect firmware configuration. Class II Boston Scientific Corporation
Oct 4, 2017 RESONATE EL ICD VR, Model D432, Sterile. The devices have an incorrect firmware configuration. Class II Boston Scientific Corporation
Oct 4, 2017 RESONATE X4 CRT-D, Model G447, Sterile. The devices have an incorrect firmware configuration. Class II Boston Scientific Corporation
Sep 22, 2017 Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be ... Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire func... Class II Boston Scientific Corporation
Sep 22, 2017 Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intende... Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire func... Class II Boston Scientific Corporation
Jun 29, 2017 EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator... The device can deliver an atypical amount of energy due to memory corruption inside the device. Class II Boston Scientific Corporation
Jun 29, 2017 EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrill... The device can deliver an atypical amount of energy due to memory corruption inside the device. Class II Boston Scientific Corporation
Jun 29, 2017 SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is inten... The device can deliver an atypical amount of energy due to memory corruption inside the device. Class II Boston Scientific Corporation
Jun 15, 2017 Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001... Boston Scientific (BSC) has received complaints for cracked trays on the Encore device. Class II Boston Scientific Corporation
Jun 1, 2017 Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above... Label on the affected devices incorrectly identifies the injection location as "above" the ball... Class II Boston Scientific Corporation
Jun 1, 2017 Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below... Label on the affected devices incorrectly identifies the injection location as "above" the ball... Class II Boston Scientific Corporation
May 15, 2017 FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is int... The device history record (DHR) was missing its test documentation for final HIPOT (high potentia... Class II Boston Scientific Corporation
Apr 5, 2017 The JETSTREAM is a rotational atherectomy catheter system designed for use in... Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lo... Class II Boston Scientific Corporation
Jan 31, 2017 AngioJet¿ Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 ... Boston Scientific has received field reports regarding the AngioJet Ultra 5000 A Console foot swi... Class II Boston Scientific Corporation
Jan 12, 2017 Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer. There is a potential for radio frequency (RF) interference to alter wireless communication from a... Class II Boston Scientific Corporation
Dec 15, 2016 Boston Scientific Imager II Angiographic Catheter, a pathway for delivering c... A field report indicated some units within this lot were missing the bottom pouch seal. The comp... Class II Boston Scientific Corporation
Dec 13, 2016 Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer p... One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The ... Class II Boston Scientific Corporation
Nov 30, 2016 Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly. Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing le... Class II Boston Scientific Corporation
Jun 15, 2016 Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and E... Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuratio... Class II Boston Scientific Corporation
Mar 28, 2016 Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Co... Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix ... Class II Boston Scientific Corporation
Mar 22, 2016 Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. P... Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving... Class I Boston Scientific Corporation
Mar 18, 2016 Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm... Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm di... Class II Boston Scientific Corporation
Dec 10, 2015 Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices ... The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it... Class II Boston Scientific Corporation
Dec 10, 2015 Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices t... The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it... Class II Boston Scientific Corporation
Nov 25, 2015 Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104... Potential for separation of the proximal handle from the shaft. Class II Boston Scientific Corporation
Nov 19, 2015 Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene o... Boston Scientific is voluntarily recalling its Chariot" Guiding Sheath. To date, Boston Scientifi... Class I Boston Scientific Corporation
Oct 9, 2015 RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev... Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque... Class I Boston Scientific Corporation
Oct 9, 2015 RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev... Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque... Class I Boston Scientific Corporation
Sep 17, 2015 Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). ... Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communi... Class II Boston Scientific Corporation

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.