Z-1040-04

Synchromed II infusion pump

Name: Z-1040-04 Synchromed II infusion pump
Creator: Medtronic Inc, Neurological & Spinal Division
Published: 2004-05-11
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2004-05-11 / Terminated

FDA source

Medtronic Inc, Neurological & Spinal Division began a recall of Synchromed II infusion pump on 2004-05-11. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1040-04
Status: Terminated
Initiated: 2004-05-11
Posted: 2004-07-20
Terminated: 2005-11-23
Recalling firm: Medtronic Neuromodulation
Product: Synchromed II infusion pump
Product code: FRN Pump, Infusion
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.
FDA 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 in commerce: 14
Distribution: Within the United States and outside the United States.
Product codes and lots: Serial numbers: NGP002428N, NGP002429N, NGP002430N, NGP002436N, NGP002437N, NGP002447N, NGP002448N, NGP002495N, NGV001296N, NGV001335N, NGV001390N, NGV001391N, NGV001433N, NGV001447N

Product code FRN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)