FDA issues recall of J&J's heart device over faulty valve

The FDA issued a Class I recall Jan. 2 for a heart device manufactured and distributed by a unit of Johnson & Johnson — citing a faulty valve, according to Reuters.

The recall affects approximately 110 Agilis Steerable Introducer Sheath devices made and distributed between Jan. 1 and May 5, 2017.

A Class I recall — defined by the FDA as "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death" — is the strictest form of recall issued by the agency.

A spokesperson for J&J declined Reuter's request for comment.

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