March 11, 2016 — Teleflex Inc. announced the worldwide recall of Arrow International intra-aortic balloon catheter kits and percutaneous insertion kits. The Arrow IAB is inserted in the aorta and provides mechanical circulatory support for cardiac patients, by inflating and deflating at different phases of the cardiac cycle to increase cardiac output and decrease the work of the heart.
The U.S. Food and Drug Administration (FDA) has classified the recall as a Class I recall. FDA defines a Class I 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.”
On Feb. 9, Teleflex initiated a worldwide recall of 47,140 units distributed to hospitals, clinics and medical centers throughout the United States and globally. The systems 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 or exsanguination may occur. Interruption or loss of intra-aortic balloon pump treatment may also occur. At the time of the recall, there were 13 adverse events reported, including six serious injuries and one death.
Teleflex notified domestic distributors and customers via an Urgent Medical Device recall letter dated Feb. 11, 2016. Consumers who have affected product should immediately discontinue use and return all affected product to Teleflex.
Teleflex has notified the FDA of this action. The full list of affected lot numbers can be found here.
For more information: www.teleflex.com