Medtronic, Inc. Recall Gets Class I Status From FDA
Published: Dec 27, 2012
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."