Agency classClass IIOur severity:High FDA (Devices)·Z-0937-2024·Announced 2024-02-07

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.

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 3/5 (High).

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
Category: Medical Device — Endoscopic Dilation Device
Hazard: device-burst
device-leak
foreign-body
Affected units: 5,031

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.

The notice also names 3 states specifically:

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.

See all 12 products in this recall →

Same manufacturer · Olympus Corporation of the Americas

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