US FDA classifies recall of Abiomed’s blood pumps as most serious

By Thomson Reuters Mar 21, 2024 | 10:10 AM

(Reuters) – The U.S. health regulator on Thursday classified the recall of blood pumps by Abiomed, a Johnson & Johnson company, 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 for patients 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 agency said there have been 129 reported serious injuries, including 49 reports of death as a result of their use.

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

Abiomed and J&J did not immediately respond to Reuters’ requests for comment.

(Reporting by Bhanvi Satija in Bengaluru; Editing by Anil D’Silva)