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

Inari Medical

23/08/2024 23:31

Aug 23 (Reuters) - The U.S. Food and Drug Administration
on Friday classified a recall of Inari Medical's  NARI.O 
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)
 ((Savyata.Mishra@thomsonreuters.com;))