In a Class 1 Recall yesterday, the U.S. Food and Drug Administration has recalled all SynchroMed El pumps with motors manufactured after September 1999.
These recalled infusion pumps are from Medtronic Neuromodulation of Minneapolis, MN, and include pump models: 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18.
The motorized pump could stall at a higher rate than other infusion pumps because of grear shaft wear. If the motor stalls in one of these recalled Medtronic infusion pumps, drug delivery will suddenly stop without warning, which could cause serious personal injury or death.
If you have any questions at all please contact Medtronic Patient Services: 800-510-6735 or visit the FDA’s Class I recall alert at www.fda.gov/cdrh/recalls/recall-080307.html.