| Subject: | Class I Recall of Abiomed, Inc., AB5000 Circulatory Support System |
| Category: | Food and Drug Administration (FDA)
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| Published: | Thu, 11 Mar 2010 - 09:00 am |
| The Food and Drug Administration (FDA) has announced the Class I recall of Abiomed, Inc., AB5000 Circulatory Support System. The product, which supplies power to disposable blood pumps used to support the left and/or right sides of the heart, were manufactured and distributed between May 2003 and December 2009.The product is being recalled because the computer may stop pumping without an alarm. This defect may cause serious injuries or death.According to the FDA, at the start of the... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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