EZDilate esophageal balloons recalled for inflation failure and device leaking
Olympus is recalling EZDilate Fixed Wire Balloons for inflation and deflation failures. The devices may burst, leak, or leave foreign material 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: FDA Class II recall with reported device failures (bursting, leaking) and reported adverse patient events (foreign body retention), meeting the criteria for Severe classification.
Plain-English summary
Olympus Corporation of the Americas is recalling EZDilate Fixed Wire Balloon devices (Model BD-400P-0880, Lot 380777) due to reported failures during endoscopic use. The devices are intended for dilation of esophageal strictures in adults and adolescents over 12 years old.
The manufacturer has received reports of problems with inflating, deflating, and retrieving the balloons. Additionally, reports describe device bursting and leaking. Some events have involved foreign material remaining in the patient, and procedures have been prolonged due to device failures.
The affected units—126 total—were distributed nationwide in the United States and internationally in Australia, Brazil, Canada, Germany, Hong Kong, India, Japan, and Singapore.
Patients or healthcare providers who have used this product should immediately discontinue use and consult with their healthcare provider. Patients who have undergone the procedure should be monitored for complications.
The recalled product
- Product
- EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 126
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 (1)
- UDI-DI: 00821925033160 Lot Number: 380777
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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