FDA Warns of Class I Recall of Abiomed Heart Pump IFU

WASHINGTON, D.C. — The Food and Drug Administration has warned that due to perforation risks, Abiomed has issued a Class I recall of the Instructions For Use for its Impella left sided heart pump.

According to the March 21 notice, the device’s catheter may perforate the wall of the left ventricle in the heart. The device has been linked to 129 serious injuries, including 49 deaths.

The pump is used to assist the pumping chambers of the heart during high-risk catheter-based procedures. It is also used in cases of ongoing cardiogenic shock following severe heart attacks, open-heart surgery, or …