The Agilis Steerable Introducer Sheath is used to insert and position cardiovascular catheters in the heart, according to an FDA Recall Notice issued Tuesday. The device features a hemostatic valve that prevents blood from flowing back through the valve, which may fail due to an improper seal of the sheath hub, the agency said.
Defective seals can cause blood to leak through the hub and the cap to fall off during implantation, or create a difference in pressure which allows air into the circulatory system (air embolism), according to the FDA.
Affected model and lot numbers include STJ408309, STJ408310, and STJG408324. The products were manufactured and distributed from Jan. 1, 2017, to May 5, 2017.
FDA said the problem 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, according to the FDA.
This is a Class I Recall, which means that use of affected Agilis Steerable Introducer Sheaths could result in severe health consequences for patients, including death.