The FDA has ordered a recall of Medtronic's SynchroMed II implantable infusion pump, models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011, according to an FDA news release.
The devices may have reduced performance due to formation of a film within the pump battery. This problem can lead to the sudden loss of therapy and the return of underlying symptoms or therapy withdrawal symptoms.
Medtronic began notifying physicians with an Urgent Medical Device Correction letter beginning July 5, 2011. The company has a device identification website where customers can enter the serial number of their SynchroMed II infusion pump to find out if it is being recalled.
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