The FDA has posted 7 enforcement recalls of programmable implanted infusion pump devices since 2025, none of them Class I (most serious). Most recent report: Jul 1, 2026.
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
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.…
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.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Pump, Infusion, Implanted, Programmable”). Informational only — verify against the FDA before acting.