FDA Issues Recall of Jonson & Jonson Heart Device

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Reuters Health Medical News

January 4, 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 (http://bit.ly/2A7nOIj).

About 110 Agilis Steerable Introducer Sheath devices made and distributed between January 1 and May 5 are a part of the Class I recall, according to the FDA (http://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.

Original headline: FDA issues recall on J&J heart device

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