FDA recall record · openFDA

Medtronic Neuromodulation

29 FDA recalls on record (2023–2026) — 29 device. 29 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Software issues were identified in application version 2.x. 4

Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interfe 2

A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. 2

Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted 1

Potential for error and inability to interrogate pump due to data corruption in the pump memory. 1

Recalls

Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following device Class II 2026-04-08 Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkins Class II 2026-05-13 Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkins Class II 2026-05-13 Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT90 Class II 2025-11-20 A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software Class II 2025-12-03 Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis P Class II 2025-03-04 Enhanced Verify Evaluation Handset (CFN HH90130FA) Class II 2025-04-03 A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System. Class II 2025-01-09 SynchroMed II Infusion Pump. Product Number: 8637-20 Class II 2024-09-11 SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL w Class II 2024-11-21 SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with Class II 2024-11-21 Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Mo Class II 2024-06-17 Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300. Class II 2024-09-24 Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator Class II 2024-03-28 Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revisi Class II 2024-05-10 SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK w Class II 2024-11-21 A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594 Class II 2024-05-15 SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMS Class II 2024-11-21 Vanta Implantable Neurostimulator (INS), Model 977006 Class II 2024-08-21 Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargea Class II 2024-09-18 Medtronic SynchroMed II, Model 8637-20, Programmable pump Class II 2023-11-13 SenSight Connector Plug, Model Number B31061. Class II 2023-01-20 Medtronic InterStim Ground Pad REF 041826 Class II 2023-07-06 Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation Class II 2023-06-06 Medtronic SynchroMed II, Model 8637-40, Programmable pump Class II 2023-11-13 A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application.. Class II 2023-06-21 Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and Class II 2023-03-17 Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators Class II 2023-10-19 Model A710 Intellis Clinician Programmer Application, version 2.0.97 Class II 2023-12-19

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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