Abiomed AB5000 Circulatory Support System Recall: Risk of Injury or Death

A Class 1 medical device recall has been issued for Abiomed, Inc.’s AB5000 Circulatory Support System after it was determined that the device, which keeps the heart pumping in cases of heart failure, can suddenly stop operating without warning.

The FDA sent out an AB5000 Circulatory Support System recall notice this week, after Abiomed sent letters to customers alerting them of the problem last month.

The computer in the device can shut down, and the system can stop pumping a patient’s heart without warning, according to the FDA statement. Although there have been no injuries reported in connection to the defective circulatory support systems, the action has been classified as a Class 1 recall because of the risk of serious injury or death.

Abiomed circulatory support systems are used to keep the right, left, or both sides of a patient’s heart pumping after heart failure temporarily until the natural heart rhythm can be restored. The device itself is linked to a portable computer console which allows the patient mobility.

The recall affects the Abiomed AB5000 Circulatory Support System, catalog number 0015-0000, with serial numbers AD5001 through AD5496. Systems with serial numbers AD5006 and AD5018 are exempt from the recall. The systems were manufactured and sold from May 2003 through December 2009 by the Massachusetts-based company.

The company contacted customers via letter on January 27, 2010. The FDA requests that any health care professionals or patients who experience an adverse medical event or reaction while using this device contact FDA’s Medwatch Adverse Event Reporting Program at http://www.fda.gov/medwatch.