Olympus Corporation of the Americas: EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-2080

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: 8294 units Lot/code info: UDI-DI: 00821925033214 Lot Numbers: 364645, 365580, 365582, 365586, 375543, 375973, 381391, 381558, 381559, 381560, 381892, 381893 382697, 382698, 383359, 383360, 383361 Added 12/1/23: 376573, 376574, 376918, 377491

UPC codes

00821925033214

Source

Official record: FDA (Device enforcement) ↗

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