Teleflex Recalls Arrow IAB Catheter Kits and Percutaneous Insertion Kits

March 11, 2016—Teleflex Incorporated announced a class 1 worldwide recall of Arrow International intra-aortic balloon (IAB) catheter kits and percutaneous insertion kits. The company initiated the action on February 9. The recall included 47,140 units distributed to hospitals, clinics, and medical centers throughout the United States and globally. Teleflex has notified the US Food and Drug Administration of this action. 

The US Food and Drug Administration defines a class 1 recall as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

Teleflex notified domestic distributors and customers via an urgent medical device recall letter dated February 11, 2016. Consumers who have affected product should immediately discontinue use and return all affected product to Teleflex.

According to Teleflex, the kits are being recalled because the sheath body may become separated from the sheath hub. If the separation occurs, the patient may bleed from the sheath. If bleeding is not promptly addressed, significant blood loss may occur. Interruption or loss of IAB pump treatment may also occur. At the time of the recall, there were 13 adverse events reported, including six serious injuries and one death.