Olympus Corporation of the Americas: EZDilate Wire Guided Balloon 11-12-13. 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: 3354 units Lot/code info: UDI-DI: 00821925033245 Lot Numbers: 369715, 370108, 370270, 370496, 377814, 378933, 379534, 386461, 386462, 388459

UPC codes

00821925033245

Source

Official record: FDA (Device enforcement) ↗

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