Olympus Corporation of the Americas: EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-

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: 2991 units Lot/code info: UDI-DI:00821925033238 Lot Numbers: 361663, 361664, 365174, 374533, 374534, 375148, 378070, 386123, 386124, 386395

UPC codes

00821925033238

Source

Official record: FDA (Device enforcement) ↗

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