A heart pump with a deadly track record of failures, including puncturing the vital organ it was designed to assist, is now the subject of the most serious type of recall issued by the U.S. Food and Drug Administration.

Heart pump manufacturer Abiomed issued an alert about its Impella Left Sided Blood Pumps that are linked to 49 deaths and 80 more reports of serious injuries, according to the FDA. The tiny pump is meant as a short-term support for the heart during complex procedures for people who have life-threatening conditions. 

“During operations, the Impella device could cut through the wall of the left ventricle,” the FDA wrote in its Class I recall alert in March. “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.”

A doctor inserts the straw-like medical device into the heart’s ventricles to ease the heart’s workload and provide support to the circulatory system during a high-risk cardiac procedure. Now the FDA warns the device could cut through the wall of the left ventricle during the operation.

More than 66,000 devices in the U.S. are impacted by the recall, according to the FDA.

What Should Impella Users Know?

Abiomed sent an urgent correction letter to all affected customers in late December 2023 warning of the dangers and warning doctors to “carefully position” the device during operations and “use special care” when inserting the pump catheter. 

“I think cardiologists are already extremely careful,” Dr. Rita F. Redberg, a cardiologist and a professor at the University of California, San Francisco, told the New York Times.

“To say that you’re addressing 49 deaths by saying ‘be careful’ is not addressing the problem at all.”

The impacted Abiomed products are:

  • Impella 2.5 
  • Impella CP
  • Impella CP with SmartAssist
  • Impella 5.0
  • Impella 5.5 with SmartAssist 
  • Impella LD

Consumers and health care professionals who experienced adverse reactions or want to report quality problems can do so by contacting the FDA’s Safety Information and Adverse Event Reporting Program. Affected patients are also filing lawsuits against the manufacturer.

Abiomed Faces FDA Scrutiny

Abiomed knew of the device’s life-threatening dangers in October 2021 when it issued a technical bulletin to doctors, warning of the potential heart perforation risk. The company failed to notify the FDA, which violates Agency protocols, an Agency spokesperson told CNN. 

The Agency sent a scathing warning letter to Abiomed in September 2023 following an FDA inspection of the company’s Danvers, Massachusetts facility earlier that year. In it were numerous complaints that the Agency said Abiomed failed to take appropriate action on and should have reported.

“Your firm should take prompt action to address any violations identified in this letter,” the letter states. “Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction and civil money penalties.”

Abiomed, which was acquired by Johnson & Johnson Medtech, boasts about its Impella heart pump on the company website. It says more than 300,000 patients are supported by the device that the FDA granted “its highest level of approval as safe and effective.”

Dr. Seth D. Bilazarian, a senior vice president of Abiomed, told the New York Times in a statement that there were no issues related to the product design or manufacturing. 

“We are proud of the positive impact our technology is having on patients facing life-threatening conditions,” Dr. Bilazarian said, adding that heart-wall tears are rare and a known complication in these types of surgeries.