Arrow International LLC (Subsidiary of Teleflex Incorporated), EIF-000561, FiberOptix Ultra 8 IAB, Ultra 8 IAB, UltraFlex IAB

Teleflex is initiating this voluntary FSCA for the above-mentioned products due to reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as:- failure of the intra-aortic balloon to completely inflate over its full length - damaged or broken central lumen in the segment contained within the balloon - helium loss or blood in the helium pathway. Possible consequences of the above issue include a reduction or loss of the hemodynamic support normally provided by IABP therapy. This would require immediate replacement of the device resulting in delay or temporary interruption of IABP therapy. Therefore, this condition could result in an increased risk of hemodynamic or ischemic complications, including death.