FDA: Class I recall of Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits

Editor's Note

The Food and Drug Administration (FDA) on March 11 announced the Class I recall of  Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits by Teleflex Incorporated (Wayne, Pennsylvania). Class I is the FDA’s most serious recall classification.

The Kits are being recalled because the sheath body may become separated from the sheath hub. If separation occurs, the patient may bleed from the sheath. If bleeding is not promptly stopped, significant blood loss or exsanguination may occur. Interruption or loss of intra-aortic balloon pump may also occur.

There have been 13 adverse events reported, including six serious injuries and one death.

Posted 03/11/2016] AUDIENCE: Cardiology, Risk Manager ISSUE: Teleflex Incorporated (NYSE: TFX) announces worldwide recall of Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits. On 9-Feb-2016, Teleflex Incorporated initiated a worldwide recall of 47,140 units distributed to hospitals, clinics, and medical centers throughout the United States and globally.