New warnings and revised instructions for use of certain types of heart pumps that can lead to a risk of cardiac perforation have been added, according to a warning issued by the pump manufacturer and posted on the U.S. Food and Drug Administration website. There are warnings.

Pump, Johnson Left Impeller Heart Pump & Johnson Medtech’s Abiomed has been linked to more than 100 serious injuries, including 49 deaths.

This alert notifies customers of new and revised warnings added to device labels. The modification includes a warning about the risk of cardiac perforation “due to operator handling,” the alert said.

Abiomed said, “Use of the affected Impella pumps can cause serious health effects, including left ventricular perforation and free wall rupture, high blood pressure, insufficient blood flow, and death.”

This warning has been identified by the FDA as a Class I recall, the most serious type of action the FDA can take if the device “has the potential to cause serious injury or death.”

Impella’s left-sided heart pump is used to reduce the work of the heart and support the circulatory system during high-risk heart surgeries.

This device, which looks like a flexible straw, is inserted through the heart’s main blood vessels and into the left ventricle (the main pumping chamber), where it helps pump blood from the heart to the body.

The risk of cardiac perforation when inserting the device was first disclosed to doctors in a technical bulletin published in October 2021. However, the company did not share this information with the FDA at the time, violating the agency’s procedures, an FDA spokesperson said.

The FDA issued a warning letter to Abiomed in September after completing an inspection of the company. Among other things, it cited the company’s failure to update the FDA on the risk of cardiac perforation it identified two years ago.

In response to this warning, Abiomed issued an Emergency Medical Device Correction Letter on December 27, requiring customers to comply with the new and revised warnings. These warnings include being careful about pump position during the procedure, using images when advancing the pump, and taking special care when inserting the pump.

Over 66,000 devices in the US are affected by this alert. The FDA said people at particular risk associated with this device may include women, the elderly, and people who have had a previous heart attack that affected the anterior wall of the heart.

According to the alert, there have been 129 reports of serious injuries, including 49 deaths, related to impeller pumps.

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

“Our commitment to quality, patient safety and reliability is the foundation of everything we do, and we continue to implement extensive process improvements as part of our full integration into Johnson. & Johnson MedTech Quality System,” Abiomed said in a statement to CNN.

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

“FDA also continues to evaluate adverse events related to the Impella system,” an FDA spokesperson said.

Medical professionals and consumers can report adverse events or quality issues with these devices on FDA’s MedWatch site.

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