The FDA has posted 12 enforcement recalls from Medtronic Neuromodulation since 2025, none of them Class I (most serious). Most recent report: Jun 3, 2026.
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest.…
Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain sympt…
Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets.…
There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
Software issues were identified in application version 2.x.
Software issues were identified in application version 2.x.
Software issues were identified in application version 2.x.
Software issues were identified in application version 2.x.
Firm name as filed with the FDA: “Medtronic Neuromodulation”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.