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

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: 00821925033184 Lot Numbers: 369624, 377715

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