EZDilate Fixed Wire Balloon Medical Device Recalled Due to Device Failures
Olympus is recalling 8,294 EZDilate Fixed Wire Balloon devices due to reports of device failures including bursting, leaking, and foreign body retention in patients undergoing esophageal dilation.
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: FDA Class II recall with reported adverse events including foreign body retention in patients and documented device failures (bursting and leaking). Although specific hospitalization or death data are not stated in the source, these device malfunctions during endoscopic procedures pose significant patient risk.
Plain-English summary
Olympus Corporation of the Americas is recalling the EZDilate Fixed Wire Balloon 18-19-20 (Model BD-400P-2080), a medical device used for endoscopic dilation of strictures of the esophagus in adults and adolescents. The recall affects 8,294 units distributed nationwide and internationally (Australia, Brazil, Canada, Germany, Hong Kong, India, Japan, Singapore).
The recall was issued due to reports of device malfunctions during inflation, deflation, and retrieval, as well as bursting and leaking. Additional reports describe events involving foreign body retention in patients and prolonged endoscopic procedures associated with these failures.
Patients and healthcare providers who have received or are using affected devices should consult with their physician regarding next steps. Healthcare facilities should contact Olympus Corporation of the Americas for device return and replacement instructions. Affected lot numbers include: 364645, 365580, 365582, 365586, 375543, 375973, 381391, 381558, 381559, 381560, 381892, 381893, 382697, 382698, 383359, 383360, 383361, 376573, 376574, 376918, and 377491.
The recalled product
- Product
- EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-2080
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 8,294
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 (19)
- UDI-DI: 00821925033214 Lot Numbers: 364645
- 365580
- 365582
- 365586
- 375543
- 375973
- 381391
- 381558
- 381559
- 381560
- 381892
- 381893 382697
- 382698
- 383359
- 383360
- 383361 Added 12/1/23: 376573
- 376574
- 376918
- 377491
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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