Olympus EZDilate Balloon Device Recalled for Inflation and Deflation Issues
Olympus is recalling approximately 6,898 EZDilate Wire Guided Balloon devices due to reported bursting, leaking, and retrieval problems during medical procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class II device with documented adverse events including foreign body retention in patients during procedures and multiple device malfunction modes (bursting, leaking, inflation/deflation failure). These reported adverse events constitute significant patient safety risks.
Plain-English summary
Olympus Corporation of the Americas is recalling the EZDilate Wire Guided Balloon (Model BD-410X-2055), a medical device used to dilate strictures in the alimentary tract during endoscopic procedures in adults and adolescents over 12 years old.
The recalled devices have been associated with failure during normal use, including problems with inflation, deflation, and retrieval. Reported issues include bursting, leaking, foreign body retention in patients, and prolonged procedures.
Approximately 6,898 units have been distributed nationwide and internationally (Australia, Brazil, Canada, Germany, Hong Kong, India, Japan, Singapore). The affected lot numbers are: 366881, 367026, 367030, 369509, 370718, 371173, 372147, 374100, 374101, 374810, 386463, 386841, 386842, 387130, and 387424.
Patients who have undergone treatment with these devices should contact their healthcare provider if they experience symptoms or complications. Healthcare facilities should review use of affected units and report any adverse events to the FDA.
The recalled product
- Product
- EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-2055
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 6,898
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 (14)
- UDI-DI: 00821925033276 Lot Numbers: 366881
- 367026
- 367030
- 369509
- 370718
- 371173
- 372147
- 374100
- 374101
- 374810
- 386463
- 386841 386842
- 387130
- 387424
Distribution
Part of a larger recall action
This product is one of 12 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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