Recall Z-1506-2025 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
| Date | Apr 1, 2025 (initiated Jan 9, 2025) |
| Status | Open, Classified |
| Reason | Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump. |
| Root cause | Under Investigation by firm |
| Action | 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 rece |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.