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Eclipse G25626Recalls & 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 00827002256262), received between May 12, 2017 and May 12, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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.

Most reported problems

Device problems

  • Burst Container or Vessel1

Patient problems

  • Foreign Body In Patient1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 12, 2017Burst Container or Vessel; Burst Container or Vessel

    DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK ECLIPSE TTC WIRE GUIDED BALLOON DILATOR. THE USER ADVANCED THE DEVICE TO DESIRED POSITION AND THE DEVICE COULD NOT BE INFLATED. THE USER WITHDREW THE DEVICE AND FOUND IT WAS LEAKING. THEY REPLACED IT WAS A NEW DEVICE TO FINISH THE PROCEDURE.

    Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

    MAUDE report 6563154 ↗

Other Dilator, esophageal devices

All Dilator, esophageal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.