Olympus Corporation of the Americas recalls EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscop
Recalled Product
EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380
Hazard / Issue
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
Issued by
FDA
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