FDA-Device2025-04-09Class II
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Medtronic Neuromodulation
Hazard
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
Sold states
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.
Affected count
4365 units
Manufactured in
7000 Central Ave Ne, Minneapolis, MN, United States
Products
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1506-2025Don't want to check this manually?
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