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.
Published December 19, 2012 · Recall initiated: November 9, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Neuromodulation
- Distributor
- Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico.
- Lot
- All SynchroMed EL and SynchroMed II pumps
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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