J&J Sterilmed Agilis Recall Issued Over Air Embolism Risk from Steerable Introducer Sheaths

Federal health officials have announced a Class I recall for steerable introducer sheaths, which are used to position cardiovascular stents in the heart. However, it appears that the sheaths may allow blood to leak and create air pockets in the circulatory system, posing a serious risk of patient injury and death. 

The FDA announced a Class I recall of Johnson & Johnson Steerable Introducer Sheath’s on January 2, after recognizing the sheaths have insufficient seals that could allow air into the circulatory system, causing an air embolism. To date, no injuries or fatalities have been reported in relation to the recall.

The devices being recalled are used to insert and position cardiovascular catheters in the heart, including on the left side of the heart through the wall of tissue that separates the right and left chambers.

According to the notice, the recalled sheaths may contain improper seals at the hemostatic valve, which is designed to prevent blood from flowing back through the valve. In the event the seals are defective, blood may leak through the hub and create a difference in pressure that allows air into the circulatory system.

When air enters the circulatory system, it causes a condition known as an air embolism, which may result in respiratory failure, heart failure, stroke, low blood pressure and loss of consciousness.

Officials from the FDA have categorized this announcement as a Class I recall, which is the most serious type of recall, suggesting that the problems may cause serious injury or death to patients.

The recall includes all Agilis Steerable Introducer Sheath’s hemostatic valves containing model numbers STJ408309, STJ408310, STJG408324 that were manufactured and distributed between January 1, 2017 through May 5, 2017.

The products were manufactured by Johnson & Johnson’s subsidiary Sterilmed of Plymouth Minneapolis, and were distributed to healthcare professionals and medical centers nationwide.

Customers are being asked to stop using the devices immediately and to quarantine any remaining inventory. Customers should share the recall information with their facilities and educate the staff of the risks.

Customers are being asked to return any remaining inventory to the manufacturer at this time. The agency would like any adverse health consequence related to the recall reported to its MedWatch adverse event reporting program.