Olympus EZDilate Endoscopic Dilation Balloons Recalled for Device Failures
Olympus is recalling 2,991 EZDilate endoscopic balloons for problems with inflation and deflation. Reports include device bursting and leaking, and retained foreign bodies in patients during procedures.
- Product
- 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
- Category
- Medical Device
- Distribution
- Distributed nationwide