Medtronic Model 8637 SynchroMed II Implantable Infusion Pump: Class I Recall - Potential for Reduced Battery Performance
MedSun: Newsletter #65, October 2011

FDA MedWatch Safety Alert

Medtronic and FDA notified healthcare professionals of a Class I recall of the SynchroMed II Infusion system. Medtronic's analysis of the problem indicates it is related to the formation of a film within the pump battery. This problem can lead to the sudden loss of therapy and the return of underlying symptoms and/or therapy withdrawal symptoms. The recall includes the SynchroMed II Implantable Infusion Pump models 8637-20 and 8637-40, distributed between May 2004 and July 8, 2011.

Additional Information:

FDA MedWatch Safety Alert. Medtronic Model 8637 SynchroMed II Implantable Infusion Pump: Class I Recall - Potential for Reduced Battery Performance. September 12, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm271510.htm


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