Z-1506-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 9, 2025
- Initiation Date
- January 9, 2025
- Termination Date
- N/A
- 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