Recall Z-0137-2025 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
SynchroMed II Infusion Pump. Product Number: 8637-20
| Date | Oct 21, 2024 (initiated Sep 11, 2024) |
| Status | Open, Classified |
| Reason | Potential for error and inability to interrogate pump due to data corruption in the pump memory. |
| Root cause | Device Design |
| Action | On 11-September-2024, a Medtronic representative was sent to the physician s facility where the representative provided the communication and confirmation form to the physician. The physician was asked to sign the confirmation form indicating they read the notification. The representative reset the patient s pump. |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of Mississippi. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.