US FDA calls Teleflex inflatable device recall ‘most serious’

US FDA calls Teleflex inflatable device recall ‘most serious’

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(Reuters) – The U.S. Food and Drug Administration has deemed the recall of Teleflex’s inflatable devices that increase blood flow to the heart muscle “most serious.”

The devices are used in patients undergoing cardiac and non-cardiac surgery, as well as in the treatment of people after heart failure or acute coronary syndrome – a group of diseases in which blood flow to the heart is reduced.

The regulator said the company recalled 16,959 Arrow FiberOptix intra-aortic balloon catheter kits and Arrow UltraFlex intra-aortic balloon catheter kits due to a manufacturing error that may have caused excessive twisting of the catheter’s inflatable balloon.

On Thursday, the FDA said Teleflex and its Arrow International unit had 322 complaints, adding that 31 injuries and three deaths had been reported that may have been related to the problem.

According to the FDA, using the device can cause serious harm, including blood loss, torn arteries, unstable blood pressure, blockage of blood flow to the heart, or death.

(Reporting by Puyaan Singh in Bengaluru; Editing by Shounak Dasgupta)