Johnson & Johnson (J&J, NYSE: JNJ), already embroiled in lawsuits over alleged cancer risks associated with its talcum powder products, faces a new product safety scandal. The company’s medical device subsidiary, Abiomed, has initiated a recall of over 66,000 Impella left-sided heart pumps due to a risk of heart perforation during procedures. The recall, which began on December 27, 2023, includes an update to the product’s instructions for use.
The US Food and Drug Administration (FDA) classified the recall as a Class I event, the most serious category, and reported receiving 129 reports of serious injuries, including 49 deaths, attributed to the issue. Abiomed’s Impella heart pump, first approved in 2008, is described as a percutaneous catheter-based support system offering hemodynamic support to the heart. The smallest heart pumps in the world, Impella devices allow the heart to rest and recover by temporarily assisting the heart’s pumping function, efficiently delivering blood and oxygen throughout the body. They are used in patients with coronary artery disease, those who have suffered a heart attack, or those awaiting a heart transplant.
Abiomed has issued four recalls to date related to the Impella pumps due to the risk of the catheter cutting through the wall of the left ventricle. The FDA’s notice states that use of the affected pumps could result in perforation or free wall rupture, hypertension, lack of blood flow, and death. The recall covers 66,000 devices distributed in the US between October 2021 and October 2023, including the Impella 2.5, Impella CP, Impella 5.0, Impella 5.5, and Impella LD models. Over 26,000 recalled devices were distributed outside the US.
An Abiomed spokesperson is quoted as saying that the recall “is not a device removal and Impella heart pumps remain on the market and available for patients,” with updated guidance on the use of Impella devices.- Flcube.com
