Abiomed initiates recall for Impella heart pump instructions following 49 deaths

Impella heart pump instructions recall overview: 

• Who: Abiomed issued a recall for the instructions for 66,390 of Abiomed’s Impella left-side heart pumps. 
• Why: The heart pumps are connected to 49 reports of death and 129 reported serious injuries.
• Where: The heart pump recall applies across the United States.
• How to get help: Consumers or their loved ones who experienced heart wall tears due to an Impella heart pump may qualify to participate in an Abiomed Impella lawsuit investigation.

Abiomed, a medical device technology company, issued a recall for the instructions of 66,390 Impella left-side heart pumps connected to 49 reports of death and 129 reported serious injuries. 

The recall includes:

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

Abiomed recalled the instructions because the pump catheter can cut into the left ventricle wall in the heart during operations, the recall notice states.

The Food and Drug Administration (FDA) classified the instructions recall as a Class I recall, the most serious variety for products that can cause serious injuries or death, according to the recall notice. Abiomed distributed the pumps between October 10, 2021, and October 10, 2023.

Doctors use the Impella heart pumps for short-term support during high-risk catheter-based procedures when there is ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack, open-heart surgery or when the heart is not functioning well due to cardiomyopathy, the recall says.

Heart pump use allowed after instructions, risks updated

Abiomed first issued notice of Impella issues in October 2021. Since then, the FDA received 21 more reports of heart wall tears linked to patient deaths, the FDA told the New York Times.

Abiomed sent updated instructions to physicians on the proper use of the pump, which includes carefully positioning the pump catheter during operative procedures.

There are 66,390 Impella heart pumps in the United States and 26,000 devices in Australia, Canada, France, India and other countries, the New York Times reports.

Doctors can still use the devices as Abiomed updated the instruction manual with the pump risks, the New York Times writes.

Consumers can contact Abiomed Inc. at 978-646-1400.

The FDA often warns consumers about potentially hazardous products. In January, it issued a warning to consumers about ingesting certain dietary supplements labeled as tejocote root after testing determined they are actually toxic yellow oleander.

Are you affected by the Impella heart pump instructions recall? Let us know in the comments. 

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