Medtronic Inc, Neurological & Spinal Division Synchromed II infusion pump Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Synchromed II infusion pump
Brand
Medtronic Inc, Neurological & Spinal Division
Lot Codes / Batch Numbers
Serial numbers: NGP002428N, NGP002429N, NGP002430N, NGP002436N, NGP002437N, NGP002447N, NGP002448N, NGP002495N, NGV001296N, NGV001335N, NGV001390N, NGV001391N, NGV001433N, NGV001447N
Products Sold
Serial numbers: NGP002428N, NGP002429N, NGP002430N, NGP002436N, NGP002437N, NGP002447N, NGP002448N, NGP002495N, NGV001296N, NGV001335N, NGV001390N, NGV001391N, NGV001433N, NGV001447N
Medtronic Inc, Neurological & Spinal Division is recalling Synchromed II infusion pump due to The opposite version serial numbers were assigned to 20mL and 40mL SynchroMed II Model 8637 pumps. This size-type indication is used by the programme. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026