Recall Z-1040-04 ยท FRN Pump, Infusion
Medtronic Inc, Neurological & Spinal Division
Synchromed II infusion pump
| Date | Jul 20, 2004 (initiated May 11, 2004) |
| Status | Terminated |
| Reason | The opposite version serial numbers were assigned to 20mL and 40mL SynchroMed II Model 8637 pumps. This size-type indication is used by the programmer to identify the pump size and can cause a limitation in the useable fill volume on a 40 mL pump and could cause some confusion related to the size of a 20 mL pump which identifies itself as a 40 mL pump. |
| Root cause | Other |
| Action | The physicians have been notified via letter of the problem with the pump. Appointments will be made with the patients and a Medtronic representative to correct the implanted devices. |
| Quantity | 14 |
| Distribution | Within the United States and outside the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.