Recall Z-0496-2013— 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: SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual.. 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.