Worldwide Medical Recall Initiated

Worldwide Medical Recall Initiated

Boston Scientific Corp. has said it is recalling all of its Felxtome Cutting Balloon systems, medical products used in cutting through fat deposits in hardened arteries.  The company cited several reports and results of studies that suggested the product has a fault in it that could result in further injury or even death in patients getting surgical procedures with the devices.

The company, one of the largest medical device makers in the world is recalling over 40,000 of its balloon systems and said that there have been no reports of any adverse effects or deaths from the unit during any actual operating room time.

The FDA is also investigating and overseeing the recall and is in charge of notifying other countries where the device might still be in use.

The balloon contains very tiny blades that are able to cut through fat deposits in arteries and create a space where the balloon can expand. 

Boston Scientific Corp. also surprised the medical community by making a $25 million bid for the medical parts manufacturer Guidant Corp., which has many problems of its own associated with faulty products.

The problem in the balloon is that the catheter can come apart during removal and parts may get lost in a patient’s body.   No other products have been affected by the recall.


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