The U.S. health regulator on Thursday classified the recall of blood pumps made by Johnson & Johnson’s Abiomed unit as the most serious and said their use could cause serious injuries or death.
The recalled devices, Impella Left Sided Blood Pumps, are used in providing short-term support to pumping chambers of the heart during some high-risk heart procedures.
Abiomed is recalling some models of the pumps as they could cut through the left ventricle wall of the heart during operations, the U.S. Food and Drug Administration said.
The use of the affected Impella 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, adding the company had sent a correction letter to affected customers with new and revised warnings.
“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 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.
