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Balloon Catheter Recalled due to Bursting.

By Burg Simpson

June 19, 2019   Ohio Dangerous Drugs and Medical Devices, Ohio Legal Updates

Balloon Catheter Recalled due to Bursting.

On June 18, 2019, the FDA reported that Cook Incorporated has recalled a balloon catheter, the Advance Enforcer 35 Focal-Force PTA Balloon Catheter 6mm x 4cm.  This catheter is used to open blocked or narrowed arteries that supply blood to the leg.

What are balloon catheters?

Balloon catheters are used to expand narrowed or blocked arteries. When used, a balloon catheter is placed in the narrowed vessel and then inflated.  The balloon’s expansion forces the narrowed artery to expand, which improves blood flow.

Why was this balloon catheter recalled?

            Like all balloons, balloon catheters will burst if they are over-inflated. This is why every balloon catheter has a “rated burst pressure,” which is the maximum inflation pressure that can be used on the device.  According to the FDA, the Advance Enforcer 35 Focal-Force PTA Balloon Catheter 6mm x 4cm was recalled because there were multiple reports that it was bursting below its rated burst pressure.

What can happen if this balloon catheter bursts?

            The FDA reports that there have been no reports of injury or death related to this balloon catheter issue thus far; however, if this product bursts, it can cause a prolonged procedure, additional intervention, vessel injury, and death.

What is being done?

            Cook, Inc. has advised all of its customers to immediately cease the use of this product. For more information regarding the recall, click here.

If you or a loved one has been injured by a burst balloon catheter, contact one of the experienced product liability attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.

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