FDA Enforcement
Class II
Ongoing
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Recall: Z-1506-2025
·
Reported April 9, 2025
Enforcement
- Recall Number
- Z-1506-2025
- Event ID
- 96237
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medtronic Neuromodulation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- April 9, 2025
- Initiation Date
- January 9, 2025
- Classification Date
- April 1, 2025
- Address
- 7000 Central Ave Ne, Minneapolis, MN, 55432-3568, United States
Description
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Reason
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
Code Info
version v.2x, UDI/DI 00763000632793
Distribution
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.
Quantity
4365 units