FDA classifies corrections to instructions for Abiomed’s BPs as Class I

The U.S. health regulator on Thursday classified corrections made to the instructions for the use of blood pumps manufactured by Johnson & Johnson’s, opens new tab Abiomed unit as most serious due to the risk of serious injuries and death with their current use.

The labeling updates, which FDA classified as its most serious Class I recall, gave revised instructions for using the device, such as carefully positioning the pump catheter during operative procedures and using imaging when advancing it.

Abiomed’s so-called recall of some models of its Impella Left Sided Blood Pumps, used in some high-risk heart procedures to provide short-term support, was because of the possibility they could cut through the left ventricle wall of the heart during operations, the FDA said.

The use of the affected pumps may also cause serious adverse health consequences, including hypertension, lack of blood flow and death, according to the health regulator.

The recall is a correction, not a product removal, the FDA said.

“This notification is not a device removal and Impella heart pumps remain on the market and available for patients,” a J&J spokesperson said.

The company said it had updated instructions for the use of the Impella system to further address the potential risk of a rare complication, left ventricular perforation.

The agency said there have been 129 reported serious injuries, including 49 reports of death as a result of their use.

The medical device maker started the recall process on Dec. 27 last year and has recalled 66,390 devices in the United States. The recalled devices were distributed for two years until Oct. 10, 2023.

Abiomed sells other pumps under the Impella brand, which are used for different therapeutic reasons.

Johnson & Johnson, opens new tab struck a massive $16.6 billion all-cash deal in 2022 to buy Abiomed to boost growth in its medical devices unit. Abiomed operates as a standalone business under J&J’s MedTech unit. Reuters