66,000 Impella Left Sided Blood Pumps (49 deaths, 100+ injuries) recalled by FDA due to catheter risk in Abiomed devices.

The US Food and Drug Administration (FDA) has issued a Class I recall for over 66,000 Impella Left Sided Blood Pumps manufactured by Abiomed, linking them to 49 deaths and over 100 serious injuries. The recall, the most serious type, was initiated due to the danger associated with the pump's catheter, which may cut through the wall of the left ventricle during operations. The devices are used to support heart pumping during high-risk catheter-based procedures and in cases of cardiogenic shock following heart attacks, open-heart surgery, or cardiomyopathy. Abiomed sent an Urgent Medical Device Correction letter to affected customers in December 2023, requesting they follow new and revised warnings. The recalled pumps were distributed from October 10, 2021, to October 10, 2023.

March 29, 2024
21 Articles