FDA Deems Medtronic Recall A Class 1

The SynchroMed II infusion pump recall, just initiated by device maker, Medtronic, has been deemed a Class I recall by the U.S. Food & Drug Administration (FDA). According to the agency, the infusion pumps may fail in certain circumstances.

As we just wrote, the FDA issued a warning that some Medtronic SynchroMed drug infusion pumps may malfunction, and this could result in serious injuries or death. A Class I recall designation is the agency’s most serious and involves situations in which there exists a reasonable probability that use of the recalled products will cause serious adverse health consequences or death.

Medtronic implemented the recall in November, said Mass Device, after it discovered “higher-than-expected” failure rates when the 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,” the FDA notice stated, according to Mass Device. “The use of unapproved drugs can lead to intermittent or permanent pump motor stall and cessation of drug infusion.”

Although motor stalls can take place whether approved or unapproved drugs are used with the devices, the stalls occur at a much higher rates when unapproved drugs are used, Mass Device explained. Medtronic recommended that healthcare providers only use the SynchroMed II with drugs approved for use with the device; information on these drugs can be found on device’s labeling, the notice stated.

As we’ve explained, data from the FDA shows that when unapproved prescription drugs are delivered through a SynchroMed infusion pump they are three times more likely to cause a malfunction. In this case, a malfunction occurs when the infusion pump motor stalls. This results in a drug not being delivered. Depending upon which prescription drug is being administered and for which purposes, the lack of the drug could result in serious injuries, severe pain, or even death.

The FDA and Medtronic are advising patients and health care professionals to provide constant monitoring of a patient using a SynchroMed pump to deliver their drugs. Infusion pumps are often used in patients who require constant or round-the-clock medical care or who must receive a certain drug on a consistent basis or over a longer period of time. The risk of a SynchroMed motor stalling is still present even if an approved drug is used and patients should always be monitored if they’re using a SynchroMed or any type of drug infusion pump.

The SynchroMed II: Models 8637-40 and 8637-20 (in 20 ml or 40 ml reservoir sizes) and the SynchroMed EL: Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18, are involved in the recall. The recalled SynchroMed Infusion Pumps were manufactured May 1998-November 2012 and April 1999-November 2012. The SynchroMed Infusion Pumps contain and administer prescribed drugs or fluids to a specific site in a patient’s body. Approved drugs for use with the SynchroMed infusion pumps are Infumorp, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate, and Gablofen.

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