Recall Z-0508-2020 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
| Date | Dec 3, 2019 (initiated Oct 11, 2019) |
| Status | Terminated |
| Reason | There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall. |
| Root cause | Process control |
| Action | Medtronic Representatives began communicating to consignees starting 10/09/2019. Beginning 10/11/2019, Medtronic sent letters via mail. The letters explained the issue and requested the return of any unused units. |
| Quantity | 10820 units |
| Distribution | US and Canada, Asia -Pacific (APAC), China, Europe, Middle East and Africa (EMAE), Latin America (LATAM) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.