January 4, 2018 — Johnson & Johnson has recalled about 110 heart devices because a defective valve could fail during or after implantation, resulting in a life-threatening emergency.
The recall involves the Agilis Steerable Introducer Sheath, according to a recall notice posted by the FDA.
The Agilis Steerable Introducer Sheath is used to insert and position cardiovascular catheters in the heart — specifically the left side of the heart through the tissue that separates the right and left chambers.
It features a hemostatic valve that is supposed to prevent blood from flowing backward through the valve. Unfortunately, it may fail due to an improper seal of the sheath hub, according to the FDA.
A defective seal could result in blood leaking through the sheath hub. This could allow the cap to fall off during implantation. It might also create a difference in pressure that allows air to enter the patient’s circulatory system, resulting in a life-threatening “air embolism.”
The recall involves Model and Lot #STJ408309, #STJ408310, and #STJG408324. They were manufactured and distributed between January 1, 2017 and May 5, 2017.
The FDA blamed the problems on glue manufacturing errors:
“The improper seal occurs when not enough glue is used to reattach the cap to the hub after reprocessing. Too much glue can also block the sheath valve and make the device unusable.”
The recall has been designated as Class 1, which is the strictest form of recall issued by the FDA, reserved for situations in which the use of a defective device may cause severe injury or death.
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