Class I recall issued for Medtronic SynchroMed infusion pumpsDec 24, 2012
The Food and Drug Administration has issued a Class I recall on two models of Medtronic SynchroMed drug infusion pumps because defects could cause them to fail to deliver a drug.
According to a recall statement from the agency, the recall involves SynchroMed drug infusion pumps manufactured since May 1998 until November 2012. They were distributed from April 1999 until November 2012. The Class I recall indicates that it is the agency's most serious warning. A Class I recall means that use of a medical device or pharmaceutical product could result in serious patient injuries or death.
The recall includes the following SynchroMed drug infusion pumps: SynchroMed II, models 8637-40 and 8637-20 (The SynchroMed II Pump is supplied 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, 8627L-18.
These specific pumps are approved to deliver the following prescription drugs: Infumorp, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen. A drug infusion pump is used for patients who require a long-term drug treatment or for those who regularly receive injection drug treatments. Problems with these recalled SynchroMed pumps mostly occur when they're used to deliver unapproved drugs.
The agency notes in its recall statement: "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 use of unapproved drugs can lead to intermittent or permanent pump motor stall and cessation of drug infusion."
A defective drug infusion pump could have serious and sometimes fatal consequences. With these SynchroMed pumps, the motor stalls unexpectedly and causes it to stop working. A faulty drug infusion pump can fail to deliver a drug on time. Depending upon the drug being delivered, this can have varying effects on patients. And while most of the incidents which have prompted this recall have involved times when an unapproved drug was used in it, there are reports of the motor stalling when an approved drug was used.
Rather than have all these drug pumps returned, Medtronic is urging health care professionals to provide vigilant monitoring of patients who rely on these specific devices. The company, along with the FDA, urges those same people to avoid using unapproved, compounded, or mixed drugs in one of these SynchroMed pumps.