The U.S. Food and Drug Administration (FDA) announced on June 13 that Teleflex/Arrow International are recalling the Arrow FiberOptix Intra-Aortic Balloon (IAB) Catheter Kit and the Arrow UltraFlex IAB Catheter Kits due to a manufacturing issue that may cause the catheter's balloon to become overtwisted, preventing full balloon inflation and resulting in patient harm.

According to the agency, this issue may "prevent the balloon from fully inflating, cause blood to back up in the tubing, allow helium to leak, and lead to catheter damage or insertion difficulty during use." This is a Class I recall, meaning use of these devices may cause serious injury or death.

For more information and recommendations for clinicians, visit the FDA website.

Keywords: ACC Advocacy, United States Food and Drug Administration, Catheters, Patient Harm