EZDilate Wire Guided Balloon Recalled for Device Malfunction and Patient Injury Risk
Olympus recalled 3,767 EZDilate Wire Guided Balloons due to reported inflation, deflation, and retrieval problems causing bursting, leaking, and foreign body lodgement in patients. The devices dilate strictures in the alimentary tract.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class II medical device recall with documented adverse events including device failures (bursting and leaking) and patient injury (foreign body in patient). Per the severity rubric, Class II recalls with significant injury reports qualify as Severe.
Plain-English summary
Olympus Corporation of the Americas is recalling 3,767 EZDilate Wire Guided Balloon devices (Model BD-410X-1555) distributed nationwide and internationally. The balloons are intended for endoscopic dilation of strictures in the alimentary tract in adults and adolescents over 12 years of age.
The recall was initiated due to reported problems with the devices including difficulties in inflating, deflating, and retrieving the balloons. Reports indicate the balloons may burst or leak during use. Events involving foreign material lodged in patients have been documented, and procedures may be prolonged due to device malfunction.
The affected devices were distributed nationwide in the United States, as well as internationally to Australia, Brazil, Canada, Germany, Hong Kong, India, Japan, and Singapore. The affected lot numbers are 372741, 373098, 373607, 378931, 378932, 380775, 380776, 387128, 388778, 388779, 389197, and 389201.
Healthcare facilities and practitioners who have these devices in inventory should cease use immediately and contact Olympus Corporation of the Americas for return and replacement instructions. Patients who have undergone procedures with these devices should contact their healthcare provider if they experience symptoms related to foreign body complications or persistent discomfort.
The recalled product
- Product
- EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1555
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 3,767
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 (12)
- UDI-DI: 00821925033252 Lot Numbers: 372741
- 373098
- 373607
- 378931
- 378932
- 380775
- 380776
- 387128
- 388778
- 388779
- 389197
- 389201
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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