Abiomed AB5000 Circulatory Support System: Class I Recall
MedSun: Newsletter #47, April 2010

FDA MedWatch Safety Alert

FDA notified healthcare professionals of the Class 1 recall of the AB5000 Circulatory Support System, a product that supplies power to disposable blood pumps used to support the left and/or right sides of the heart. The computer may shut down (stop pumping) without an alarm and this defect may cause serious injuries or death.

Additional Information:

FDA MedWatch Safety Alert. Abiomed AB5000 Circulatory Support System: Class I Recall. March 10, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm203956.htm


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