medical Class II Updated 2024-02-07

Olympus Corporation of the Americas recalls EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for e

Recalled Product

EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1555


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

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00821925033252 Lot Numbers: 372741, 373098, 373607, 378931, 378932, 380775, 380776, 387128, 388778, 388779, 389197, 389201
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