FDA Device recall Z-1681-2015
Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40
- FDA Device
- Class II
- terminated
- Published 2015-06-03
On 2015-06-03 the FDA classified a Class II recall of Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40 by Medtronic Neuromodulation, citing medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease to function.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1681-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-10 |
| Published | 2015-06-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
Product
Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter
Reason
Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease to function.
Identifiers
| code_info | US Serial Number NGP411628H NGP411629H NGP411685H NGP411704H NGP411801H NGV501193H NGP410146H NGP410147H NGP41…US Serial Number NGP411628H NGP411629H NGP411685H NGP411704H NGP411801H NGV501193H NGP410146H NGP410147H NGP410148H NGP410149H NGP410151H NGP410153H NGP410156H NGP410160H NGP410162H NGP410163H NGP410169H NGP410171H NGP410175H NGP410177H NGP410178H NGP410179H NGP410181H NGP410182H NGP410183H NGP410184H NGP410186H NGP410188H NGP410189H NGP410190H NGP410191H NGP410196H NGP410197H NGP410198H NGP410200H NGP410201H NGP410204H NGP410206H NGP410213H NGP410215H NGP410216H NGP410217H NGP410219H NGP410220H NGP410221H NGP410223H NGP410230H NGP410231H NGP410233H NGP410234H NGP410237H NGP410240H NGP410241H NGP410244H NGP410950H NGP410956H NGP410964H NGP410968H NGP410969H NGP410970H NGP410976H NGP410978H NGP410979H NGP410982H NGP410989H NGP410992H NGP411000H NGP411009H NGP411012H NGP411015H NGP411017H NGP411018H NGP411042H NGP411047H NGP411052H NGP411053H NGP411056H NGP411062H NGP411063H NGP411064H NGP411065H NGP411070H |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1681-2015%22
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