Agency classClass IIOur severity:High FDA (Devices)·Z-0935-2024·Announced 2024-02-07

Olympus EZDilate Fixed Wire Balloon Device Recalled for Inflation and Deflation Failures

Olympus recalls 1,008 EZDilate Fixed Wire Balloon devices nationwide due to malfunction during use. Reported failures include inflation and deflation problems, bursting, leaking, and foreign body events 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 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: FDA Class II device with reported device failures (bursting and leaking) and patient adverse events (foreign body in patient, prolonged procedures), but no hospitalizations or injuries explicitly reported in the source.

Plain-English summary

The U.S. Food and Drug Administration has issued a Class II recall for the EZDilate Fixed Wire Balloon (Model BD-400P-1380), an endoscopic device used to dilate strictures of the esophagus in adults and adolescents 12 years of age and older. A total of 1,008 units have been recalled nationwide, with additional units distributed internationally to Australia, Brazil, Canada, Germany, Hong Kong, India, Japan, and Singapore.

The device has experienced malfunction issues during use, including problems with inflation, deflation, and retrieval. Reported failures include device bursting, leaking, and events involving foreign bodies in patients, as well as prolonged procedures.

Healthcare providers who possess these devices should discontinue use immediately and contact Olympus Corporation of the Americas for return or replacement instructions. Patients who have received treatment with this device should consult their healthcare provider if they experience any complications.

The recalled product

Product: EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Endoscopic Device
Hazard: device-malfunction
burst
leaking
foreign-body
Affected units: 1,008

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 (2)

UDI-DI: 00821925033184 Lot Numbers: 369624
377715

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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