Tuesday, March 16, 2010

Heart Device Recall

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The FDA has told health care providers of an ongoing recall launched by Abiomed, Inc for a device that supplies power to a blood pump used on failing hearts.

Abiomed began warning customers in December of a potential defect in some AB5000 circulatory support systems that could cause the computer in the device to shut down the blood pump without any alarm. The company followed this up with a letter dated January 27, that was delivered when company representatives repaired the devices.

Here is info from the FDA site:

Reason for Recall:

The computer may shut down (stop pumping) without an alarm. This defect may cause serious injuries or death.

FDA Comments:

At the start of the recall, the company phoned their customers and followed up with a letter dated January 27, 2010. The sales representatives delivered the letter at the time the product repairs were carried out.


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