Teleflex has announced a worldwide recall of Arrow International intra-aortic balloon catheter kits and percutaneous insertion kits. The Arrow 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 announced that the US Food and Drug Administration (FDA) has classified the recall as a Class I recall—“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.”
In February, Teleflex initiated a worldwide recall of 47,140 units distributed to hospitals, clinics, and medical centres throughout the USA and globally. 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 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 has notified domestic distributors and customers via an Urgent Medical Device recall letter. Consumers who have affected product should immediately discontinue use and return all affected product to Teleflex. Teleflex has notified the FDA of this action.