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Abiomed AB5000 Circulatory Support System: Class I Recall
Audience: Cardiovascular surgery healthcare professionals, hospital risk managers, biomedical engineers
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. These products were manufactured and distributed between May 2003 and December 2009.
Read the complete MedWatch 2010 Safety summary, including a link to the FDA Recall Notice at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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