Endoscopic Dilation Balloons Recalled for Bursting and Leaking Failures
Olympus recalled 3,354 EZDilate wire-guided dilation balloons due to failures in inflation, deflation, and retrieval, with incidents of bursting, leaking, and foreign bodies left in patients.
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: This is an FDA Class II recall with reported incidents resulting in foreign bodies left in patients, a significant adverse event. The reported bursting, leaking, and retrieval failures represent material patient safety risks during endoscopic procedures.
Plain-English summary
Olympus Corporation of the Americas has recalled 3,354 EZDilate wire-guided dilation balloons (Model BD-410X-1355) due to reported device failures. The affected units are distributed nationwide and in several international markets including Australia, Brazil, Canada, Germany, Hong Kong, India, Japan, and Singapore.
The EZDilate balloons are used for endoscopic dilation of strictures in the digestive tract in adults and adolescents over 12 years old. Reported issues include problems with inflating and deflating the balloon, failure to retrieve the device properly, bursting, and leaking. These failures have resulted in incidents where foreign bodies remained in patients and procedures took longer than expected.
Patients and healthcare providers who have received units from affected lot numbers—369715, 370108, 370270, 370496, 377814, 378933, 379534, 386461, 386462, and 388459—should discontinue use and contact Olympus Corporation for instructions on device replacement or safe disposal.
The recalled product
- Product
- EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1355
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 3,354
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: 00821925033245 Lot Numbers: 369715
- 370108
- 370270
- 370496
- 377814
- 378933
- 379534
- 386461
- 386462
- 388459
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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