Agency classClass IIOur severity:Severe FDA (Devices)·Z-0940-2024·Announced 2024-02-07

Olympus EZDilate Endoscopic Dilation Balloons Recalled for Device Failures

Olympus is recalling 2,991 EZDilate endoscopic balloons for problems with inflation and deflation. Reports include device bursting and leaking, and retained foreign bodies in patients during procedures.

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 medical device with documented device failures (bursting, leaking, inflation/deflation malfunction) and reported adverse events including retained foreign bodies in patients, which constitute significant procedural complications.

Plain-English summary

Olympus Corporation of the Americas is recalling 2,991 EZDilate Wire Guided Balloons (Model BD-410X-1055) used for endoscopic dilation of strictures in the alimentary tract. The affected lot numbers are 361663, 361664, 365174, 374533, 374534, 375148, 378070, 386123, 386124, and 386395. The devices are distributed nationwide and internationally in Australia, Brazil, Canada, Germany, Hong Kong, India, Japan, and Singapore.

The balloons have experienced problems with inflation, deflation, and device retrieval. Reported issues include device bursting and leaking. Healthcare providers have reported events involving retained foreign bodies in patients during procedures, associated with prolonged procedures.

Healthcare providers using these balloons should immediately stop use of the affected lot numbers and contact Olympus for replacement devices. Facilities should review patient records of procedures performed with these specific lots.

The recalled product

Product: EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-1055
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Endoscopic Dilation
Hazard: device-rupture
device-leakage
retained-foreign-body
Affected units: 2,991

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:00821925033238 Lot Numbers: 361663
361664
365174
374533
374534
375148
378070
386123
386124
386395

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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