Medtronic recalls SynchroMed E1 pumps that might fail

  • Updated: February 4, 2008 - 10:33 PM

The Food and Drug Administration on Monday recalled a drug pump made by Fridley-based Medtronic Inc. after some of the device's motors failed, preventing therapy to patients.

The implantable pumps deliver drugs to specific areas of the body to treat pain, spasticity and cancer. Medtronic said no deaths or serious injuries have been reported related to the malfunction.

About 52,000 patients worldwide have SynchroMed El pumps -- about 8,000 of them have the type of pump that could fail. The pumps, no longer used in the United States, were made before September 1999.

According to an FDA alert, some of the pump's motors may stall, halting delivery of pain-relieving drugs to the patient. Some patients experiencing drug withdrawal may die if not treated immediately, the FDA said.

Pumps made before September 1999 experienced a rate of motor stalls of 2.2 percent seven years after implant, the company said.

Medtronic alerted doctors to the problem in August, advising them to closely monitor patients. On Monday, the FDA classified the action as a class 1 recall, the most serious type, involving a situation where there is a "reasonable probability" that the product will cause serious injury or death.

The affected models of the SynchroMed El implantable pump are: 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18 and 8627L-18. The company phased out the models after the SynchroMed II pump was introduced in 2004. The pumps were made in Fridley and Puerto Rico.

Medtronic's stock closed Monday at $47.55 per share, down 30 cents.

JANET MOORE

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