The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0944-2024·Announced 2024-02-07

Olympus EZDilate Balloon Device Recalled for Inflation and Deflation Issues

Olympus is recalling approximately 6,898 EZDilate Wire Guided Balloon devices due to reported bursting, leaking, and retrieval problems during medical 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 device with documented adverse events including foreign body retention in patients during procedures and multiple device malfunction modes (bursting, leaking, inflation/deflation failure). These reported adverse events constitute significant patient safety risks.

Plain-English summary

Olympus Corporation of the Americas is recalling the EZDilate Wire Guided Balloon (Model BD-410X-2055), a medical device used to dilate strictures in the alimentary tract during endoscopic procedures in adults and adolescents over 12 years old.

The recalled devices have been associated with failure during normal use, including problems with inflation, deflation, and retrieval. Reported issues include bursting, leaking, foreign body retention in patients, and prolonged procedures.

Approximately 6,898 units have been distributed nationwide and internationally (Australia, Brazil, Canada, Germany, Hong Kong, India, Japan, Singapore). The affected lot numbers are: 366881, 367026, 367030, 369509, 370718, 371173, 372147, 374100, 374101, 374810, 386463, 386841, 386842, 387130, and 387424.

Patients who have undergone treatment with these devices should contact their healthcare provider if they experience symptoms or complications. Healthcare facilities should review use of affected units and report any adverse events to the FDA.

The recalled product

Product
EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-2055
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscopic Dilation Device
Hazard
Affected units
6,898

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 (14)

  • UDI-DI: 00821925033276 Lot Numbers: 366881
  • 367026
  • 367030
  • 369509
  • 370718
  • 371173
  • 372147
  • 374100
  • 374101
  • 374810
  • 386463
  • 386841 386842
  • 387130
  • 387424

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 →

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