EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855

Reason: 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.

Code information: UDI-DI: 00821925033269 Lot Numbers: 360769, 360770, 368258, 368259, 368844, 369417, 385724, 387425, 387426, 387794, 387795

Distribution pattern: Nationwide. Foreign: AU BR BR CA DE HK IN JP SG