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.
FDA MedWatch Safety Alert. Abiomed AB5000 Circulatory Support System: Class I Recall. March 10, 2010.