The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0938-2024·Announced 2024-02-07

EZDilate Fixed Wire Balloon Medical Device Recalled Due to Device Failures

Olympus is recalling 8,294 EZDilate Fixed Wire Balloon devices due to reports of device failures including bursting, leaking, and foreign body retention in patients undergoing esophageal dilation.

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 recall with reported adverse events including foreign body retention in patients and documented device failures (bursting and leaking). Although specific hospitalization or death data are not stated in the source, these device malfunctions during endoscopic procedures pose significant patient risk.

Plain-English summary

Olympus Corporation of the Americas is recalling the EZDilate Fixed Wire Balloon 18-19-20 (Model BD-400P-2080), a medical device used for endoscopic dilation of strictures of the esophagus in adults and adolescents. The recall affects 8,294 units distributed nationwide and internationally (Australia, Brazil, Canada, Germany, Hong Kong, India, Japan, Singapore).

The recall was issued due to reports of device malfunctions during inflation, deflation, and retrieval, as well as bursting and leaking. Additional reports describe events involving foreign body retention in patients and prolonged endoscopic procedures associated with these failures.

Patients and healthcare providers who have received or are using affected devices should consult with their physician regarding next steps. Healthcare facilities should contact Olympus Corporation of the Americas for device return and replacement instructions. Affected lot numbers include: 364645, 365580, 365582, 365586, 375543, 375973, 381391, 381558, 381559, 381560, 381892, 381893, 382697, 382698, 383359, 383360, 383361, 376573, 376574, 376918, and 377491.

The recalled product

Product
EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-2080
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscopic Dilation Device
Hazard
Affected units
8,294

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 (19)

  • UDI-DI: 00821925033214 Lot Numbers: 364645
  • 365580
  • 365582
  • 365586
  • 375543
  • 375973
  • 381391
  • 381558
  • 381559
  • 381560
  • 381892
  • 381893 382697
  • 382698
  • 383359
  • 383360
  • 383361 Added 12/1/23: 376573
  • 376574
  • 376918
  • 377491

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 →

Related recalls

Same manufacturer · Olympus Corporation of the Americas

See all →

Same hazard · device failure

See all →

Similar recalls