Medtronic SynchroMed EL Implantable Infusion Pumps Recalled

February 4, 2008

In a Class 1 Recall yesterday, the U.S. Food and Drug Administration has recalled all SynchroMed El pumps with motors manufactured after September 1999.

These recalled infusion pumps are from Medtronic Neuromodulation of Minneapolis, MN, and include pump models: 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18.

The motorized pump could stall at a higher rate than other infusion pumps because of grear shaft wear. If the motor stalls in one of these recalled Medtronic infusion pumps, drug delivery will suddenly stop without warning, which could cause serious personal injury or death.

If you have any questions at all please contact Medtronic Patient Services: 800-510-6735 or visit the FDA’s Class I recall alert at www.fda.gov/cdrh/recalls/recall-080307.html.

Were you affected? Click Here for a free case evaluation!

Comments

One Response to “Medtronic SynchroMed EL Implantable Infusion Pumps Recalled”

  1. Patrice E. Vealey on March 6th, 2009 2:50 pm

    I ned to know if Mdtronics will pay for the new pump to be implanted since it is their equipment failure and recall. This will be the 5th pump installed for various failures – some the Dr.’s and some the pumps. Please contat me as soon as posible since my new Dr. is alking about replacing this pumpi or before July of this year. Thank you.

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