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.
Related Articles on Recalls of Infusion Pumps:
Infusion Pumps Plagued by Multiple FDA Recalls
Medtronic Issues Warning for SynchroMed II Implantable Painkiller Pumps
FDA Launches New Initiative to Address Infusion Pump Safety Issues
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