Eclipse G25633Recalls & reported problems
Cook Incorporated · Eclipse TTC Wire Guided Balloon Dilator · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002256330), received between Aug 13, 2026 and Aug 13, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50236416 ↗
Other Dilator, esophageal devices
- CRE Fixed Wire M00558380Boston Scientific Corporation · Dilator, esophageal359 reports
- CRE Fixed Wire M00558370Boston Scientific Corporation · Dilator, esophageal219 reports
- XXL™ Esophageal M001145590Boston Scientific Corporation · Dilator, esophageal116 reports
- Olympus BD-400P-2080Gyrus ACMI, LLC · Dilator, esophageal1 recall60 reports
- CRE Wireguided M00558500Boston Scientific Corporation · Dilator, esophageal1 recall58 reports
- Olympus BD-400P-1580Gyrus ACMI, LLC · Dilator, esophageal2 recalls4 reports
- XXL™ Esophageal M001145520Boston Scientific Corporation · Dilator, esophageal102 reports
- EZDilate BD-410X-1055Gyrus ACMI, LLC · Dilator, esophageal2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.