SynchroMed E1 Pumps Cause Another Medtronic Recall
Monday, February 04, 2008
The FDA recalled SynchroMed El pumps, a heart product from Medtronic, on February 4, 2008 after reviewing reports that the pumps motors failed. The recalled SynchroMed El pumps were manufactured in Fridley, Minnesota and Puerto Rico.To date, no fatalities or serious injuries related to the products have been reported, the Minneapolis Star Tribune reported. Approximately, 52,000 patients currently have the device, and roughly 8,000 of them have the type could fail. The pumps, which were made before September 1999, are no longer used in the United States.
These pumps dispense pain-relieving drugs that are being dispensed to patients. If a patients pumps stalls, and fails the patient can experience drug withdrawal, which could eventually lead to death if not treated.
Medtronic informed physicians about this problem back in August 2007. Medtronic urged doctors to monitor patients with the device. The affected models of the SynchroMed El implantable pump are: 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18 and 8627L-18. Medtornic said it phased out those models after it introduced the SynchroMed II pump in 2004.