Synchromed II infusion pump
FDA device recall Z-1040-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Medtronic Inc, Neurological & Spinal Division
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 14
- Distribution
- Within the United States and outside the United States.
- Date initiated
- 2004-05-11
- Date posted
- 2004-07-20
- Date terminated
- 2005-11-23
- Location
- Columbia Heights, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.