A class I recall of two infusion pumps manufactured by Medtronic has been issued by the U.S. Food and Drug Administration after the motor on the pumps failed when used with drugs not specifically approved for them. The SynchroMed II Implantable and SynchroMed EL Implantable infusion pumps may stall and stop drug delivery which can lead to serious effects and even patient deaths.
The drugs morphine (Infumorph), baclofen (Lioresal and Gablofen ), ziconotide (Prialt), floxuridine, and methotrexate are all approved for use with the pumps. Accortding to Medtronic, the device has 2.4% failure rate when used with those drugs. The failure rate climbs to 7% when used with unapproved drugs. Medtronic warned healthcare professionals that if a patient’s infusion pump motor stalls, that patient should be monitored for the possible return of baseline symptoms. In addition to recalling the infusion pumps, Medtronic will also continue to investigate motor gear corrosion, “which has been identified as a primary contributor to permanent motor stall.” Medtronic also warned healthcare professionals not to use the pumps to dispense compounded drugs, unapproved concentrations, and unapproved formulations.
The two Medtronic infusion pumps being recalled are models 8637-40 and 8637-20 of SynchroMed II and several models of SynchroMed EL: 8626-10 and 8626L-10; 8626-18 and 8626L-18; 8627-10 and 8627L-10; and 8627-18 and 8627L-18. The pumps are being recalled as Class I.
Class I recalls affect products with a reasonable risk of serious adverse events or death with use. In 2011, the FDA issued two other Class I recalls on the pumps. One of the infusion pumps recalled that year had battery problems and the other was recalled because of “pocket fills” that occurred during pump refills.
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