Olympus EZDilate Balloon Dilators Recalled for Device Malfunction and Retained Foreign Bodies
Olympus recalled EZDilate Wire Guided Balloon endoscopic dilators due to reports of bursting, leaking, and retained foreign bodies during patient procedures. The Class II recall affects 4,182 units used to treat esophageal strictures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for an endoscopic device with reported malfunction incidents including bursting, leaking, and retained foreign bodies in patients. While no hospitalizations or serious injuries are explicitly reported in the source, the documented adverse events during invasive medical procedures indicate significant risk of patient harm.
Plain-English summary
Olympus Corporation of the Americas is recalling the EZDilate Wire Guided Balloon, Model BD-410X-1855, an endoscopic medical device used to dilate strictures in the alimentary tract in adults and adolescents over 12 years old. Approximately 4,182 units have been distributed nationwide and to Australia, Brazil, Canada, Germany, Hong Kong, India, Japan, and Singapore.
The recall was issued after reports of device malfunction including failures during inflation and deflation, inability to properly retrieve the device, bursting, and leaking. In addition, there have been reports of foreign bodies retained in patients and prolonged procedures during use.
Healthcare providers and facilities should identify affected units using the lot numbers provided (360769, 360770, 368258, 368259, 368844, 369417, 385724, 387425, 387426, 387794, 387795) and discontinue use immediately. Patients who have received this device should contact their healthcare provider to discuss any concerns.
For complete information, contact Olympus Corporation of the Americas or consult the FDA recall database.
The recalled product
- Product
- EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- device-malfunction
- bursting
- leaking
- retained-foreign-body
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- UDI-DI: 00821925033269 Lot Numbers: 360769
- 360770
- 368258
- 368259
- 368844
- 369417
- 385724
- 387425
- 387426
- 387794
- 387795
Distribution
Distributed nationwide across the United States.
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