Boston Scientific Cryoablation Recall
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cathetersReuters
•FDA classifies recall of Boston Scientific catheters as 'most serious'
77% Informative
U.S. Food and Drug Administration classified recall of Boston Scientific's catheters as "most serious" The recall involves updating instructions for use rather than removing the device, POLARx Cryoablation Balloon Catheters .
The company is revising the use instructions of the catheter due to a higher-than-anticipated number of reports of esophageal injury.
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