Olympus Corporation of the Americas: 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-410

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Nationwide. Foreign: AU BR BR CA DE HK IN JP SG Quantity: 4182 units Lot/code info: UDI-DI: 00821925033269 Lot Numbers: 360769, 360770, 368258, 368259, 368844, 369417, 385724, 387425, 387426, 387794, 387795

UPC codes

00821925033269

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.