Olympus Corporation of the Americas: EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1880

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: 5031 units Lot/code info: UDI-DI: 00821925033191 Lot Numbers: 365375, 365823, 365824, 365825, 369028, 382273, 382350, 382351, 383160 Added 12/1/23: 376575, 376888,376914

UPC codes

00821925033191

Source

Official record: FDA (Device enforcement) ↗

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