Medtronic Neuromodulation
Complete recall history across all FDA and CPSC categories — 95 total recalls
Medtronic Neuromodulation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (95)
FDA medical device enforcement actions by Medtronic Neuromodulation. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| May 13, 2026 | Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Sti... | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled w... | Class II |
| May 13, 2026 | Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Sti... | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled w... | Class II |
| Apr 8, 2026 | Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software ... | Software issue: When programming the SynchroMed Pump with the A810 CP App in... | Class II |
| 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 du... | Class II |
| 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 t... | Class II |
| Apr 3, 2025 | Enhanced Verify Evaluation Handset (CFN HH90130FA) | Evaluation handsets may not be able to communicate with the neurostimulator d... | Class II |
| 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 ... | Class II |
| Jan 9, 2025 | A820 myPTM Software Application associated with Medtronic SynchroMed Pump and... | Product complaints were received describing the A820 myPTM app taking longer ... | Class II |
| 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 |
| 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 |
| 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 |
| 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 |
| Sep 24, 2024 | Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300. | A limited number of Percept RC Implantable Neurostimulators (INS), Model B353... | Class II |
| 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 sessi... | Class II |
| Sep 11, 2024 | SynchroMed II Infusion Pump. Product Number: 8637-20 | Potential for error and inability to interrogate pump due to data corruption ... | Class II |
| Aug 21, 2024 | Vanta Implantable Neurostimulator (INS), Model 977006 | Model 977006 Vanta INS batterty life has depleted faster than HCPs or patient... | Class II |
| 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 pairi... | Class II |
| 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 limit... | Class II |
| 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 878... | Class II |
| Mar 28, 2024 | Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator | inability to reprogram one device | Class II |
| Dec 19, 2023 | Model A710 Intellis Clinician Programmer Application, version 2.0.97 | Medtronic has discovered an instance in which the Intellis A710 Clinician Pro... | Class II |
| Nov 13, 2023 | Medtronic SynchroMed II, Model 8637-40, Programmable pump | Medtronic recently identified that if the SynchroMed II pump switches into te... | Class II |
| Nov 13, 2023 | Medtronic SynchroMed II, Model 8637-20, Programmable pump | Medtronic recently identified that if the SynchroMed II pump switches into te... | Class II |
| 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 ... | Class II |
| Jul 6, 2023 | Medtronic InterStim Ground Pad REF 041826 | Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the produc... | Class II |
| 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 ... | Class II |
| Jun 6, 2023 | Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal cho... | A cardioversion procedure may damage the electronics in the Vanta INS device,... | Class II |
| Mar 17, 2023 | Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler... | Medtronic has received reports of SenSight Extension Tunneler kits that conta... | Class II |
| Jan 20, 2023 | SenSight Connector Plug, Model Number B31061. | Medtronic is requesting return of a small number of units of the SenSight Con... | Class II |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected De... | Class II |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected De... | Class II |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected De... | Class II |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected De... | Class II |
| Dec 3, 2022 | Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems ... | Software anomalies, CP App messages: "Too Many Device Found", "Unexpected De... | Class II |
| Jul 26, 2022 | Vanta Clinician Programmer Application, Model A71200. For programming of the... | Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.245... | Class II |
| Jul 26, 2022 | Vanta Clinician Programmer Application, Model A71200. For programming of the... | Potential communication issue in which the Vanta Clinician Programmer Applica... | Class II |
| 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)... | Class II |
| Mar 30, 2022 | Percept BrainSense Implantable Neurostimulator (INS), Model B35200 | The Implantable Neurostimulator (INS) cannot communicate with the clinical pr... | Class II |
| Mar 30, 2022 | Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200 | The Implantable Neurostimulator (INS) cannot communicate with the clinical pr... | Class II |
| Mar 30, 2022 | Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with Adap... | The Implantable Neurostimulator Model may be susceptible to not communicating... | Class II |
| 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 applicati... | Class II |
| 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 Kit... | Class II |
| 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 Kit... | Class II |
| 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 Kit... | Class II |
| Oct 19, 2021 | Model B35200 - Percept PC BrainSense Implantable Neurostimulator | During cardioversion events, the Model B35200 Percept PC Implantable Neurosti... | Class II |
| Sep 23, 2021 | Clinician Programmer Application (CPA) model A610 Clinician Software Application | A software anomaly may occur with the clinician programmer application. | Class II |
| 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 lea... | Class II |
| 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 |
| 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 ... | Class II |
| 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 ... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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