Olympus Corporation of the Americas recalls EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic
Recalled Product
EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-0855
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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