EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080
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-0934-2024