FDA-Device2024-02-07Class II
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855
Olympus Corporation of the Americas
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.
Sold states
Nationwide. Foreign: AU BR BR CA DE HK IN JP SG
Affected count
4182 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0943-2024Don't want to check this manually?
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