Recall Z-0497-2013— Medtronic Neuromodulation

Class I FDA medical device recall by Medtronic Neuromodulation, initiated 2012-11-09, terminated 2017-12-31. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.. Reason: Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion. UPDATE 2/1/2016: Medtronic received approval to incorporate enhancements to the SynchroMed II pump which decreases the potential for internal electrical shorting and motor corrosion, and is retrieving any unused pumps..

Recalling firm

Medtronic Neuromodulation

Classification

Class I

Status

Terminated

Initiated

2012-11-09

Terminated

2017-12-31

Firm location

Minneapolis, MN, United States

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