The FDA has announced its highest-level recall for Impella heart pumps after 129 reports of serious injuries, including 49 deaths.

The alert includes warnings about the risk of deadly heart perforations “due to operator handling.”

The problem is that during operations to insert the Impella device into the patient’s heart, doctors can accidentally cut through the wall of the heart and puncture their left ventricle, which is the main pumping chamber of the heart.

According to the FDA warning:

“The use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death.”

The recall involves Impella left-sided heart pumps, which are used to temporarily pump blood and keep patients alive after a heart attack, during open heart surgery, or when the heart is not functioning well.

The Impella device looks like a flexible straw that is threaded through the major blood vessels of the heart and into the left ventricle, where it helps move blood out of the heart and into the body.

The recall was announced by Abiomed, which is a part of Johnson & Johnson MedTech.

The company first disclosed the risk of heart perforation in October 2021, when Abiomed sent physicians a technical bulletin.

This information was not shared with the FDA, in violation of federal laws regarding safety reporting, according to a warning letter the FDA sent to Abiomed in September 2023.

Abiomed sent doctors an Urgent Medical Device Correction letter in December 2023, urging customers to adhere to new and revised warnings. The warnings involve more than 66,000 devices that were distributed in the U.S. between October 2021 and October 2023.

Source: Abiomed Recalls the Instructions for Use for Impella Left Sided Blood Pumps due to Perforation Risks

Posted by Daily Hornet

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