FDA Medical devices recall ·
A820 myPTM Software Application associated with Medtronic SynchroMed Pump… recall
- Recall number
- Z-1506-2025
- Date
- (initiated January 9, 2025)
- Company / brand
- Medtronic Neuromodulation
7000 Central Ave Ne, Minneapolis, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4365 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1506-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.