Medtronic Neuromodulation recalls A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
- Recall date
- January 9, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1506-2025
- FDA classification
- Class II
- Brand / firm
- Medtronic Neuromodulation
- Sold / distributed
- 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.
Why it was recalled
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
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