Teleflex is initiating this voluntary correction 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 Recall start date: April 30, 2024
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