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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