FDA recall Z-1506-2025

Medtronic Neuromodulation · Class II · device

Product

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.

Distribution

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Puerto Rico, Spain, Sweden, Switzerland, United Kingdom.

Key facts

Status
Ongoing
Initiation date
2025-01-09
Report date
2025-04-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1506-2025