A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
- Company
- Medtronic Neuromodulation
- Recall Initiated
- January 9, 2025
- Posted
- April 1, 2025
- Recall Number
- Z-1506-2025
- Quantity
- 4365 units
- Firm Location
- Minneapolis, MN
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
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.
Lot / Code Info
version v.2x, UDI/DI 00763000632793
Root Cause
Under Investigation by firm
Action Taken
Medtronic issued an URGENT: MEDICAL DEVICE correction notice to its consignees on 02/28/2025 via email or US mail. The notice explained the issue and provided recommendations to temporarily mitigate the problem, and requested the following: Actions " Share this notice with all those who need to be aware of this issue within your organization and maintain a copy of this notice in your records. " Please provide a copy of the attached patient letter to your affected patients. " Please complete and return the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information. The form may be emailed to neuro.quality@medtronic.com. For questions regarding this communication, please contact Medtronic Technical Services at 1-800-707-0933 or your local Medtronic representative.