EZDilate Fixed Wire Balloon Recalled for Device Failure and Foreign Body Risk
Olympus recalls approximately 5,031 EZDilate Fixed Wire Balloons due to device bursting, leaking, and foreign body incidents during esophageal dilation procedures. Patients should contact their healthcare provider if they received this device.
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: This is an FDA Class II device with documented functional failures (bursting and leaking) and reported incidents of foreign body in patients, presenting a clear risk of harm. However, no injuries or hospitalization outcomes are specified in the recall notice.
Plain-English summary
Olympus Corporation of the Americas is recalling the EZDilate Fixed Wire Balloon (Model BD-400P-1880), a medical device used for endoscopic dilation of esophageal strictures in patients 12 years and older. Approximately 5,031 units have been distributed.
The device has experienced functional failures including bursting and leaking during inflation, deflation, or retrieval. Additionally, there are reports of foreign body incidents where device components became trapped in patients. These problems have resulted in prolonged procedures.
The device was distributed nationwide and internationally. The recalled lot numbers are: 365375, 365823, 365824, 365825, 369028, 382273, 382350, 382351, 383160, 376575, 376888, and 376914. Patients who have received this device should contact their healthcare provider to discuss any concerns.
The recalled product
- Product
- EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1880
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- device-burst
- device-leak
- foreign-body
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 (11)
- UDI-DI: 00821925033191 Lot Numbers: 365375
- 365823
- 365824
- 365825
- 369028
- 382273
- 382350
- 382351
- 383160 Added 12/1/23: 376575
- 376888
- 376914
Distribution
Distributed nationwide across the United States.
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