Teleflex Voluntarily Recalls Arrow Intra-Aortic Balloon Pumps

Wayne, Pa.-based Teleflex is voluntarily recalling 47,140 units of its Arrow International intra-aortic balloon pump catheters, following 13 adverse events, including six serious injuries and one death.

The recall, which the FDA has deemed Class 1, was initiated due to risk of the sheath body disconnecting from its hub and resulting in “significant blood loss or exsanguination” or “loss of intra-aortic balloon pump treatment,” the company said.

Teleflex informed distributors and customers in a recall letter dated Feb. 11. — Anisa Jibrell