FDA: Class I recall of Cook Medical’s Transseptal Needle

Editor's Note

The Food and Drug Administration on March 18 identified the recall by Cook Medical Inc (Bloomington, Indiana) of one lot of its Transseptal Needles as Class I, the most serious.

The recall was initiated because of a manufacturing error that resulted in some needle tips missing the back bevel that creates a sharp tip. Without the bevel, the needle tip could damage the inside of the introducer sheath during insertion resulting in detached plastic fragments.

Transseptal Needles are used by surgeons to access the left side of the heart during cardiac procedures.

The Lot Number is 8833687. Distribution dates were May 30, 2018 to November 5, 2018.