Teleflex Recalls ARROW International Intra-Aortic Balloon Catheter Kits

Teleflex Incorporated has announced a worldwide recall of its ARROW International Intra-Aortic Balloon Catheter 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.

Teleflex officials said the U.S. Food and Drug Administration (FDA) has classified the recall of ARROW International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits 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 ARROW International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion 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 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. 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 affected products include the following code numbers: IAB-05830-LWS; IAB-05830-U; IAB-05840-LWS; IAB-05840-U; IAB-06830-U; IAB-06840-U; IAB-S730C; IAK-06845; and IAK-S7IT. A full listing of all affected products can be found in the original recall notice.

Consumers with questions may contact the company at 866-246-6990; adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Teleflex is a global provider of medical devices used in critical care and surgery, serving healthcare providers with specialty devices for vascular access, general and regional anesthesia, urology, respiratory care, cardiac care and surgery. The company is headquartered in Morrisville, N.C.