FDA: Several SynchroMed EL Implantable Infusion Pump models recalled

February 6, 2008

FDA recalls several SynchroMed EL Implantable Infusion Pump models

FDA has issued a Class I recall of Medtronic Inc., SynchroMed EL Implantable Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The models were recalled because there is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors manufactured before September 1999. The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. If a pump motor stalls, drug delivery will stop suddenly and without warning. This stoppage will result in loss of therapy, return of the patient's symptoms, and/or symptoms of drug underinfusion or withdrawal. Healthcare professionals and patients with questions should contact the manufacturer.