US FDA Classifies Recall of Teleflex’s Inflatable Devices as ‘Most Serious’

Reuters

11:57 JST, June 14, 2024

June 13 (Reuters) – The U.S. Food and Drug Administration classified a recall of Teleflex’s TFX.N 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 have acute coronary syndrome, a group of diseases in which blood flow to the heart decreases.

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.

Teleflex and its Arrow International unit reported 322 complaints, the FDA said on Thursday, adding that 31 injuries and 3 deaths were reported potentially related to this issue.

Use of the device may cause serious injury, including blood loss, artery tears, unstable blood pressure, prevention of blood flow to the heart, or death, according to the FDA.