Medical technologies provider Teleflex has recalled Arrow international intra-aortic balloon (IAB) catheter kits and percutaneous insertion kits across the globe.
The Arrow IAB, which will be inserted in the aorta, offers 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.
On 9 February, the company started a worldwide recall of 47,140 units supplied to hospitals, clinics and medical centers across the US and globally.
The company said that the products were recalled because the sheath body may become separated from the sheath hub.
The patient is expected to bleed from the sheath, if the separation occurs, while significant blood loss or exsanguination may occur, if bleeding is not promptly addressed.
According to the company, the US Food and Drug Administration (FDA) has classified the recall of Arrow international IAB kits and percutaneous insertion kits as a class I recall.
FDA defined 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.
Teleflex produces solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care.
It markets products under the Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rusch and Weck brands.