EZDilate Endoscopic Balloon Devices Recalled for Malfunction and Foreign Body Risk
Olympus is recalling EZDilate Fixed Wire Balloon devices used for esophageal stricture treatment due to reports of inflation/deflation failures, bursting, leaking, and foreign body retention in patients.
- Product
- EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
- Category
- Medical Device
- Distribution
- Distributed nationwide