AB5000 Recall
AB5000 Recall
March 13, 2010 (Danvers, Massachusetts)— The FDA is classifying Abiomed's repairs of some AB5000 circulatory support systems as a class I recall, indicating that the issue could cause serious injury or death [1].
The AB5000 system supplies power to disposable blood pumps that support the left and/or right sides of failing hearts in the hospital. In December, the Danvers, MA company began warning customers of the potential for the device's computer to shut down the blood pump without any warning or alarm.
The company followed the phone call with a letter dated January 27, 2010, which sales representatives delivered when the company repaired the devices.
The affected devices were manufactured between May 2003 and December 2009.
March 13, 2010 (Danvers, Massachusetts)— The FDA is classifying Abiomed's repairs of some AB5000 circulatory support systems as a class I recall, indicating that the issue could cause serious injury or death [1].
The AB5000 system supplies power to disposable blood pumps that support the left and/or right sides of failing hearts in the hospital. In December, the Danvers, MA company began warning customers of the potential for the device's computer to shut down the blood pump without any warning or alarm.
The company followed the phone call with a letter dated January 27, 2010, which sales representatives delivered when the company repaired the devices.
The affected devices were manufactured between May 2003 and December 2009.
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