The U.S. Food and Drug Administration announced a Class I recall for Impella Left Sided Blood Pumps, warning that the medical device could cause serious injury or death.

The Impella devices, made by Ambiomed under Johnson & Johnson’s MedTech segment, are linked to 129 reports of serious injuries, including 49 deaths, according to the FDA. 

This straw-like device provides temporary support to the heart of patients undergoing complex cardiac procedures or who have life-threatening conditions. But it could puncture the ventricle wall during insertion or use, the FDA warned.

“During operations, the Impella device could cut through the wall of the left ventricle,” the FDA announced in the alert issued 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.”

There are at least 66,000 medical devices impacted by the recall notice, according to the FDA.

Troubled Abiomed Impella Pumps

Abiomed first raised the warning about issues with the medical device by posting a technical bulletin in October 2021, but the company failed to warn the FDA of serious adverse events. In late December 2023, Abiomed sent an urgent correction letter to all its affected customers warning of the dangers and urging caution by health care workers inserting the device.

“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.”

Many Abiomed Impella devices were named in the recall notice, including:

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

Devices included in the recall were distributed between Oct. 10, 2021, and Oct. 10, 2023.

People who may be affected by the recall include those who are undergoing heart procedures using the Impella Left Sided Blood Pumps, people who have heart disease or elderly persons or women, according to the FDA. If you’ve been affected, you can report adverse reactions or quality problems to the FDA’s Safety Information and Adverse Event Reporting Program.

Affected patients are filing Abiomed Impella heart pump lawsuits, claiming the device is defective and caused serious injury or death. Litigation is still in the early stages.

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FDA Issues Warning Letter to Abiomed

According to the Abiomed website, at least 300,000 Impella devices are in use. In a statement issued to the New York Times, a company senior vice president told the newspaper 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 told the NYT, adding that heart-wall tears are rare and a known complication in these types of surgeries. 

The FDA inspected the company’s Danvers, Massachusetts facility in early 2023. A scathing letter sent to the firm in September 2023 noted many complaints and noted the company failed to take appropriate action following the serious adverse events and deaths related to the heart pump.

“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.”