The regulator said the company recalled 16,959 of its Arrow FiberOptix Intra-Aortic Balloon Catheter Kits and Arrow UltraFlex Intra-Aortic Balloon Catheter Kits due to a manufacturing error that could cause the catheter's inflatable balloon to become overtwisted.
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US FDA classifies recall of Teleflex's inflatable devices as 'most serious'
June 13, 2024
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