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-410X-1055
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.
Nationwide. Foreign: AU BR BR CA DE HK IN JP SG
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0940-2024