(Reuters) – The U.S. Food and Drug Administration on Tuesday issued a recall of a heart device made by a unit of Johnson & Johnson due to a faulty valve.
The valve, which prevents blood from flowing back through it, is part of a device used to insert and position cardiovascular catheters in the heart. (bit.ly/2A7nOIj)
About 110 Agilis Steerable Introducer Sheath devices made and distributed between Jan. 1 and May 5 are a part of the Class I recall, according to the FDA. (bit.ly/2lFe3N6)
A Class I recall is the strictest form of recall issued by the health regulator, in situations where the use of faulty devices may cause serious injury or death.
Johnson & Johnson did not immediately respond to a request for comment.
Reporting by Manas Mishra in Bengaluru; Editing by Shounak Dasgupta