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.
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 medical device with documented device failures (bursting, leaking, inflation/deflation malfunction) and reported adverse events including retained foreign bodies in patients, which constitute significant procedural complications.
Plain-English summary
Olympus Corporation of the Americas is recalling 2,991 EZDilate Wire Guided Balloons (Model BD-410X-1055) used for endoscopic dilation of strictures in the alimentary tract. The affected lot numbers are 361663, 361664, 365174, 374533, 374534, 375148, 378070, 386123, 386124, and 386395. The devices are distributed nationwide and internationally in Australia, Brazil, Canada, Germany, Hong Kong, India, Japan, and Singapore.
The balloons have experienced problems with inflation, deflation, and device retrieval. Reported issues include device bursting and leaking. Healthcare providers have reported events involving retained foreign bodies in patients during procedures, associated with prolonged procedures.
Healthcare providers using these balloons should immediately stop use of the affected lot numbers and contact Olympus for replacement devices. Facilities should review patient records of procedures performed with these specific lots.
The recalled product
- 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
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 2,991
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 (10)
- UDI-DI:00821925033238 Lot Numbers: 361663
- 361664
- 365174
- 374533
- 374534
- 375148
- 378070
- 386123
- 386124
- 386395
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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