Medtronic recall gets Class I status from FDA | MassDevice.com On Call

December 26, 2012 by MassDevice staff

The FDA slaps Medtronic's SynchroMed II drug pump recall with Class I status over concerns that the devices may fail when used with unapproved drugs.

MassDevice On Call

MASSDEVICE ON CALL — The FDA slapped Medtronic's (NYSE:MDT) recall with Class I status over concerns that the medical device maker's SynchroMed II infusion pumps may fail in certain circumstances.

Medtronic initiated a recall on the devices in November after finding higher-than-expected rates of failure when the implantable SynchroMed II pumps were used with "unapproved drugs."

"Based on data from the firm's Implantable Systems Performance Registry, the overall failure rate of the SynchroMed II pump at 78 months post implant is 2.4% when used to dispense approved drugs, and 7.0% when used to dispense unapproved drugs," according to the FDA notice. "The use of unapproved drugs can lead to intermittent or permanent pump motor stall and cessation of drug infusion."

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Motor stalls can occur with either approved or unapproved drugs, the company noted, but occurred at much higher rates with unapproved drugs.

Medtronic is recommending that healthcare providers use the SynchroMed II only with drugs approved on the device's labeling, according to the notice.

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