Company: Medtronic Neuromodulation
Date of Enforcement Report: 6/3/2015
Class lI:

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 Recall Number Z-1681-2015

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.

RECALLING FIRM/MANUFACTURER
Medtronic Neuromodulation, Minneapolis, MN on 4/10/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
1901 (1576 US, 325 OUS)

DISTRIBUTION
Nationwide and Internationally

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