Browse Device Recalls
95 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 95 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 95 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 3, 2025 | A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and... | Complaints received that Vanta A71200 CP App does not function as intended during use. There is a... | Class II | Medtronic Neuromodulation |
| Nov 20, 2025 | Restore Clinician Programmer Application (CP App), Model A71100 used with the... | Software issue where a Device Reset message displayed on the app was unable to be cleared. In rar... | Class II | Medtronic Neuromodulation |
| Apr 3, 2025 | Enhanced Verify Evaluation Handset (CFN HH90130FA) | Evaluation handsets may not be able to communicate with the neurostimulator due to handsets havin... | Class II | Medtronic Neuromodulation |
| Mar 4, 2025 | Stimulation RC Clinician Programmer Application, Model A71400, when used with... | There is a software issue that can permanently disable communication with an implantable neurosti... | Class II | Medtronic Neuromodulation |
| Jan 9, 2025 | A820 myPTM Software Application associated with Medtronic SynchroMed Pump and... | Product complaints were received describing the A820 myPTM app taking longer than expected for pa... | Class II | Medtronic Neuromodulation |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Sep 24, 2024 | Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300. | A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able ... | Class II | Medtronic Neuromodulation |
| Sep 18, 2024 | Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components... | The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. | Class II | Medtronic Neuromodulation |
| Sep 11, 2024 | SynchroMed II Infusion Pump. Product Number: 8637-20 | Potential for error and inability to interrogate pump due to data corruption in the pump memory. | Class II | Medtronic Neuromodulation |
| Aug 21, 2024 | Vanta Implantable Neurostimulator (INS), Model 977006 | Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading t... | Class II | Medtronic Neuromodulation |
| Jun 17, 2024 | Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programm... | A subset of the handsets within the kit may not be able to complete the pairing process with the ... | Class II | Medtronic Neuromodulation |
| May 15, 2024 | A610 Clinician Programmer (CP) Software Application (app) with the following ... | Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI ... | Class II | Medtronic Neuromodulation |
| May 10, 2024 | Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 878... | Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of th... | Class II | Medtronic Neuromodulation |
| Mar 28, 2024 | Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator | inability to reprogram one device | Class II | Medtronic Neuromodulation |
| Dec 19, 2023 | Model A710 Intellis Clinician Programmer Application, version 2.0.97 | Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application ... | Class II | Medtronic Neuromodulation |
| Nov 13, 2023 | Medtronic SynchroMed II, Model 8637-40, Programmable pump | Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to ... | Class II | Medtronic Neuromodulation |
| Nov 13, 2023 | Medtronic SynchroMed II, Model 8637-20, Programmable pump | Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to ... | Class II | Medtronic Neuromodulation |
| Oct 19, 2023 | Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimula... | Units distributed in Korea and Turkey that did not have the correct firmware installed to support... | Class II | Medtronic Neuromodulation |
| Jul 6, 2023 | Medtronic InterStim Ground Pad REF 041826 | Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with... | Class II | Medtronic Neuromodulation |
| Jun 21, 2023 | A901 Communication Manager Application, used in conjunction with the A710 Cli... | When an update to the A710 Clinician Programmer software application for the Intellis Neurostimul... | Class II | Medtronic Neuromodulation |
| Jun 6, 2023 | Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal cho... | A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unre... | Class II | Medtronic Neuromodulation |
| Mar 17, 2023 | Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler... | Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers wit... | Class II | Medtronic Neuromodulation |
| Jan 20, 2023 | SenSight Connector Plug, Model Number B31061. | Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502... | Class II | Medtronic Neuromodulation |
| Jul 26, 2022 | Vanta Clinician Programmer Application, Model A71200. For programming of the... | Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unex... | Class II | Medtronic Neuromodulation |
| Jul 26, 2022 | Vanta Clinician Programmer Application, Model A71200. For programming of the... | Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200... | Class II | Medtronic Neuromodulation |
| May 27, 2022 | LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device. | There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepanc... | Class II | Medtronic Neuromodulation |
| Mar 30, 2022 | Percept BrainSense Implantable Neurostimulator (INS), Model B35200 | The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the ... | Class II | Medtronic Neuromodulation |
| Mar 30, 2022 | Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200 | The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the ... | Class II | Medtronic Neuromodulation |
| Mar 30, 2022 | Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with Adap... | The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical p... | Class II | Medtronic Neuromodulation |
| Feb 28, 2022 | MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the fo... | There is a software anomaly with the InterStim X Clinician software application with results in t... | Class II | Medtronic Neuromodulation |
| Nov 4, 2021 | Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Ki... | The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsi... | Class II | Medtronic Neuromodulation |
| Nov 4, 2021 | Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Ki... | The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsi... | Class II | Medtronic Neuromodulation |
| Nov 4, 2021 | Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Ki... | The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsi... | Class II | Medtronic Neuromodulation |
| Oct 19, 2021 | Model B35200 - Percept PC BrainSense Implantable Neurostimulator | During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become... | Class II | Medtronic Neuromodulation |
| Sep 23, 2021 | Clinician Programmer Application (CPA) model A610 Clinician Software Application | A software anomaly may occur with the clinician programmer application. | Class II | Medtronic Neuromodulation |
| Jul 9, 2021 | Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) ... | Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing ... | Class II | Medtronic Neuromodulation |
| Jun 2, 2021 | Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3... | Excess nylon flash on the clip. | Class II | Medtronic Neuromodulation |
| Mar 25, 2021 | Intellis Model 97755 Recharger - Product Usage: designed to charge the follow... | There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger. | Class II | Medtronic Neuromodulation |
| Mar 9, 2021 | A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Pr... | There are two issues within this correction action: 1. Cycling Issue: When copying settings fro... | Class II | Medtronic Neuromodulation |
| Nov 19, 2020 | Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC ... | A software anomaly in the A620 Patient Programmer application was identified that results in fail... | Class II | Medtronic Neuromodulation |
| Nov 12, 2020 | Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Progra... | A710 Intellis Clinician Application has a software issue that can result in the inability to prog... | Class II | Medtronic Neuromodulation |
| Jul 17, 2020 | Restore Clinician Programmer Application Software, model number A71100, used... | The original version of the A71100 Restore Clinician Programmer Application has been identified t... | Class II | Medtronic Neuromodulation |
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.