June 13 (Reuters) - The U.S. Food and Drug

Administration classified a recall of Teleflex's ( TFX )

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 ( TFX ) 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.