Teleflex's Inflatable Devices Face 'Most Serious' Recall by US FDA
Reuters
June 14, 2024
The U.S. Food and Drug Administration classified a recall of Teleflex's inflatable devices that increase blood supply to the heart muscle as "most serious."
The devices are used in patients undergoing cardiac and non-cardiac surgery and to treat those who have had heart failure or acute coronary syndrome, a group of diseases in which blood flow to the heart decreases.
The U.S. Food and Drug Administration (FDA) reported that 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.
Teleflex and its Arrow International unit reported 322 complaints, according to the FDA. The agency added that 31 injuries and 3 deaths were reported as potentially related to this issue.
The FDA noted that use of the device may cause serious injury, including blood loss, arterial tears, unstable blood pressure, prevention of blood flow to the heart, or death.
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