Medical Devices
Worldwide recall made for Flextome cutting balloon systems
Published in Medical Letter on the CDC and FDA, January 15th, 2006
No other Boston Scientific Cutting Balloon products are affected by this recall.
The company is initiating this recall because it has determined through complaints and testing that the distal shaft of the catheter may separate during withdrawal of the device. A shaft separation may prolong the procedure or require additional surgery. A total of eight complaints involving patients have been received by the company, of which three required...
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