January 4, 2018 — About 110 heart devices were recalled by a subsidiary of Johnson & Johnson due to the risk of life-threatening complications associated with a defective valve.
The FDA announced a recall for the Agilis Steerable Introducer Sheath, a device that helps insert and position cardiovascular catheters in the left side of the heart.
The Agilis Steerable Introducer Sheath has a hemostatic valve that is designed to prevent the backward flow of blood through the valve. The problem is that a defective seal could cause the valve to fail.
The improper seal of the sheath hub could result in blood leaking through the sheath hub, according to the FDA. This might result in the cap falling off during implantation. It could also potentially create a pressure difference that allows air into the circulatory system — a life-threatening complication also known as an “air embolism.”
The FDA blamed the problems on 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 involves Model and Lot #STJ408309, #STJ408310, and #STJG408324, manufactured and distributed from January 1, 2017 through May 5, 2017.
The FDA designated the recall as Class 1, the most serious type of recall the agency can issue. Class 1 recalls are reserved for situations when using a defective device could result in severe injury or death.
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