EZDilate Wire Guided Balloon Recalled for Device Malfunction Issues
Olympus recalls EZDilate Wire Guided Balloon devices used for endoscopic dilation due to reported bursting, leaking, and retrieval failures affecting 1,639 units nationwide.
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 reported significant adverse events including foreign body in patient and device malfunctions (bursting, leaking), which constitute material injury concerns.
Plain-English summary
Olympus Corporation of the Americas is recalling the EZDilate Wire Guided Balloon 6-7-8 (Model BD-410X-0855), a medical device used for endoscopic dilation of strictures in the alimentary tract in adults and adolescents over 12 years of age.
The recall is being issued due to reported problems with device inflation, deflation, and retrieval. Reports indicate the devices may burst or leak during use, and some cases involved foreign bodies in the patient and prolonged procedures.
The recall affects 1,639 units distributed nationwide and internationally to Australia, Brazil, Canada, Germany, Hong Kong, India, Japan, and Singapore. Affected lot numbers are 373808, 374005, 379746, 379747, 379835, 379836, and 381157.
Patients and healthcare providers who have received or used these devices should contact Olympus Corporation of the Americas for information regarding the recall and appropriate management.
The recalled product
- Product
- EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-0855
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,639
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 (7)
- UDI-DI: 00821925033221 Lot Numbers: 373808
- 374005
- 379746
- 379747
- 379835
- 379836
- 381157
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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