Z-1506-2025 Class II Ongoing
FDA device recall Z-1506-2025 was initiated by Medtronic Neuromodulation on Jan 9, 2025 and is designated Class II. Reason for recall: Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump. The recall status is ongoing. Affected quantity: 4365 units.
Recall details
- Product Type
- Devices
- Report Date
- Apr 9, 2025
- Initiation Date
- Jan 9, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4365 units
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.
Distribution pattern
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.
Code information
version v.2x, UDI/DI 00763000632793
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1506-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026