Olympus Corporation of the Americas: EZDilate Wire Guided Balloon 18-19-20. 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: 6898 units Lot/code info: UDI-DI: 00821925033276 Lot Numbers: 366881, 367026, 367030, 369509, 370718, 371173, 372147, 374100, 374101, 374810, 386463, 386841 386842, 387130, 387424

UPC codes

00821925033276

Source

Official record: FDA (Device enforcement) ↗

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