Recall Z-1506-2025— Medtronic Neuromodulation

Class II · Ongoing

Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2025-01-09. FDA's recall record names no specific 510(k) clearance for this event. Product: A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.. Reason: Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump..

Recalling firm
Medtronic Neuromodulation
Classification
Class II
Status
Ongoing
Initiated
2025-01-09
Firm location
Minneapolis, MN, United States

Product description

A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.

Reason for recall

Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.

Data sourced from openFDA. This site is unofficial and independent of the FDA.