A820 myPTM Software Application associated with recall
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Why was A820 myPTM Software Application associated with recalled?
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
version v.2x, UDI/DI 00763000632793
- Product
- A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 4365 units
- 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.
- Recall date
- April 9, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)