Teleflex and its subsidiary Arrow International issued a recall of its intra-aortic balloon catheter kits due to a manufacturing error that may cause the balloon to become overtwisted.
The FDA has identified this as a Class I recall, the most serious type of recall, as use of these devices (FiberOptix and UltraFlex, Arrow) may cause serious injury or death. Of note, this recall is a correction, not a product removal.
If the intra-aortic balloon becomes overtwisted, it may cause blood loss, artery perforation, hemodynamic instability, myocardial ischemia or death, according to an alert from the