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FDA issues recall on J&J heart device

Written by: | no-reply@reuters.com | Dated: Tuesday, January 2nd, 2018

 

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. 

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. 

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)

 

Reuters source:

https://www.reuters.com/article/us-johnson-johnson-fda/fda-issues-recall-on-jj-heart-device-idUSKBN1ER1L6

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