Olympus EZDilate Fixed Wire Balloon Device Recalled for Inflation and Deflation Failures
Olympus recalls 1,008 EZDilate Fixed Wire Balloon devices nationwide due to malfunction during use. Reported failures include inflation and deflation problems, bursting, leaking, and foreign body events in patients.
- Product
- EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380
- Category
- Medical Device
- Distribution
- Distributed nationwide