One person has died and another six have suffered serious injuries in connection with Teleflex’s Arrow catheter kit
The Arrow International Intra-Aortic Balloon (Arrow IAB) Catheter Kit 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 the worldwide recall of its Arrow IAB catheter kit and Percutaneous Insertion Kits last week after there were 13 adverse events reported; including six serious injuries and one death.
The US Food and Drug Administration (FDA) has classified the recall of the Arrow IAB catheter kits and Percutaneous Insertion Kits as a Class I recall which is “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 initiated the worldwide recall of 47,140 units distributed to hospitals, clinics and medical centers throughout the United States and globally last week as the device’s 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, according to the company. Interruption or loss of intra-aortic balloon pump treatment may also occur.
Teleflex notified domestic distributors and customers via an Urgent Medical Device recall letter dated February 11, 2016. Consumers who have affected product should immediately discontinue use and return all affected product to Teleflex.