US FDA classifies recall of Inari’s catheter devices as ‘most serious’

(Reuters) – The U.S. Food and Drug Administration on Friday classified a recall of Inari Medical’s ClotTriever catheter that helps capture and remove large clot from big vessels as “most serious”.

The affected products include all devices and lot numbers with labeled dates prior to Aug. 1, 2024, whose use might cause serious adverse health consequences, including device entrapment, vessel damage, and/or blockage of lung arteries and death, the FDA said.

There have been four reported injuries and six reports of death, according to the statement by the health regulator.

(Reporting by Savyata Mishra in Bengaluru; Editing by Arun Koyyur)