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The U.S. Food and Drug Administration has announced that Abiomed Inc. has completed a recall of a cardiovascular device. The Danvers-based company alerted the FDA in April that the device, called the iPulse Circulatory Support System, could fail to work during transport of the patient.
The device provides mechanical circulatory support to patients suffering from acute cardiovascular failure. Abiomed executives said in their April letter to the FDA that the console on the device could potentially flash a “low pressure/low flow” alarm and stop pumping if it is working on battery power while transporting a patient.
The recall affected Abiomed (Nasdaq: ABMD) devices distributed throughout the U.S. and in Germany, Greece, Italy, Latvia, Spain and Turkey
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