Olympus EZDilate Balloons Recalled for Bursting, Leaking, and Retrieval Failure
Olympus is recalling EZDilate Fixed Wire Balloons used for esophageal dilation due to reports of bursting, leaking, and difficulty retrieving the device. The recall affects 1,796 units distributed nationwide and internationally.
- Product
- 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
- Category
- Medical Device
- Distribution
- Distributed nationwide