CLASS II ONGOING Device recall · Reported 9 Apr 2025 · FDA Enforcement Report
A820 myPTM recalled by Medtronic Neuromodulation
Medtronic Neuromodulation is recalling A820 myPTM, distributed nationwide in the US. The recall was initiated on 9 Jan 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1506-2025
- FDA event ID
- 96237
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jan 2025
- FDA classified
- 1 Apr 2025
- Reported
- 9 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 9 Jan 2025 | Recall initiated by company | |
| 1 Apr 2025 | Classified by FDA | +82 days |
| 9 Apr 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Where it was 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.
Questions about this recall
Why was it recalled?
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
Which lots are affected?
version v.2x, UDI/DI 00763000632793
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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