New warnings about heart pumps linked to 49 deaths

By Mira Cheng, CNN

(CNN) — There are new and revised warnings about the instructions for use of a certain type of heart pump that could lead to a risk of heart perforation, according to an alert issued by the pump’s manufacturer and posted on the US Food and Drug Administration’s website.

The pumps, left-sided Impella heart pumps made by Johnson & Johnson MedTech’s Abiomed, have been linked to more than 100 serious injuries, including 49 deaths.

The alert advises customers of new and revised warnings added to the labeling of the devices. The corrections include warnings about the risk of heart perforation “due to operator handling,” according to the alert.

“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,” Abiomed said.

The alert is identified by the FDA as a Class I recall, the most serious type of action that the agency can take when a device “may cause serious injuries or death.”

The Impella left-sided heart pumps are used to reduce the work of the heart and support the circulatory system during high-risk cardiac procedures.

The device, which looks like a flexible straw, is threaded through the major vessels of the heart and into the left ventricle – the main pumping chamber – where it helps pump blood out of the heart and into the body.

The risk of heart perforation during insertion of the devices was first disclosed to physicians in a technical bulletin posted in October 2021. However, the company did not share this information with the FDA at that time, violating agency protocols, an FDA spokesperson said.

The FDA issued a warning letter to Abiomed in September after completing an inspection of the firm. Among other things, it cited the company’s failure to update the FDA about the risk of heart perforation that it had identified two years prior.

As a result of this warning, Abiomed issued an Urgent Medical Device Correction letter on December 27, requesting that customers adhere to new and revised warnings. These warnings include careful positioning of the pump during procedures, using imaging when advancing the pump and using special care when inserting the pump.

More than 66,000 devices in the US are affected by this alert. The FDA said people with specific risks related to the device may include women, the elderly and people with previous heart attacks that affected the front wall of the heart.

There have been 129 serious injuries reported, including 49 reports of death linked to the Impella pumps, according to the alert.

There have been multiple recall notices regarding three Abiomed devices in the past year.

“A commitment to quality, patient safety, and reliability is the basis for everything we do, and we continue to implement broad process improvements as part of our full integration into the Johnson & Johnson MedTech quality systems,” Abiomed said in a statement to CNN.

An FDA spokesperson told CNN the agency is “committed to evaluating any new information from Abiomed and other sources.”

“The FDA will also continue to assess adverse events associated with the Impella system,” the FDA spokesperson said.

Health care professionals and consumers can report adverse events or quality problems pertaining to these devices on the FDA’s MedWatch site.

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