Teleflex (NYSE:TFX) said today that it’s recalling nearly 50,000 of its Arrow International intra-aortic balloon pump catheters due to the risk of the sheath body detaching from its hub, after 13 adverse event reports including 6 serious injuries and 1 death.
If the sheath body detaches from the hub, the patient may lose blood through the sheath, potentially leading to “significant blood loss or exsanguination” and the loss of balloon pump therapy, the Wayne, Pa.-based company said.
The FDA slapped the worldwide recall of 47,140 Arrow International IABPs and percutaneous insertion kits with Class I status, Teleflex said, denoting the risk of serious injury or death.
The company notified customers of the recall in a Feb. 11 letter instructing them to discontinue using the product and quarantine it until it can be returned to Teleflex.
