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.
Patrice E. Vealey says
I ned to know if Mdtronics will pay for the new pump to be implanted since it is their equipment failure and recall. This will be the 5th pump installed for various failures – some the Dr.’s and some the pumps. Please contat me as soon as posible since my new Dr. is alking about replacing this pumpi or before July of this year. Thank you.
Michael Woods McCausland says
I have the model 82627L-18. It is on the recall letter dated February 4, 2008. The pump was originally implanted on May 4th 2004. After two years the pump began to function erratically. Some times it would not deliver any medication causes a state of withdrawal. It was not until 2010 (12/15) that the pump was finally removed. The representative for Medtronic. Informed me that the pump should have come out at approximately five years post implant. Not one MD, informed me of any recall nor that he pump was past its’ prime and would not work at its’ highest level.Leading to possible intermittent withdrawal syndrome. Another interesting fact was provided by the Medtronic Technician )phone). He informed me that the pump I had was “New.” Because of this the alarm (beep) would turn to a two-tone sound shortly. It never did. Leading me to speculate that this is a refurbished device. Which I was never consulted about. Is it possible to track down the history from the device with the serial number? It is 8627L-18 / SN NCH043141R . I would appreciate your help with this matter. thank you. Sincerely, Michael Woods McCausland
alicia says
My pump after the second year it leakuot all the meds in to my spinal cord causing a blockage on my legs had to rush to the ER. To stop the pump. It was finally removed 2/14/11.pump 8627L-18. Made by medtronic. If given the choise to an upgraded pump I’ll think twice todoit again. Thanks for listening.