Eclipse G25630Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002256309), received between Jan 3, 2017 and Aug 6, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 reports).

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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Leak/Splash; Off-Label Use

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160233 ↗
• MalfunctionJun 8, 2026Leak/Splash; Off-Label Use

  DURING AN DUODENAL PAPILLA STRICTURE DILATION THE PHYSICIAN USED A COOK ECLIPSE TTC WIRE GUIDED BALLOON DILATOR. IT WAS REPORTED THAT THE USER ATTEMPTED TO INFLATE THE BALLOON WITH WATER AND DISCOVERED THE BALLOON LEAKING ISSUE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430754 ↗
• MalfunctionDec 29, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  DURING AN ESOPHAGEAL BALLOON DILATION, THE PHYSICIAN USED A COOK ECLIPSE TTC WIRE GUIDED BALLOON DILATOR. IT WAS REPORTED [THAT] THE USER ADVANCED THE DEVICE THROUGH WIRE GUIDE AND OVER THE STENOSIS AREA, THEN INFLATED THE BALLOON WITH NO PRESSURE AND FOUND THE [BALLOON] LEAKING. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23913945 ↗
• MalfunctionMar 24, 2025Material Rupture; Material Rupture

  DURING AN ESOPHAGEAL BALLOON DILATION, THE PHYSICIAN USED A COOK ECLIPSE TTC WIRE GUIDED BALLOON DILATOR. IT WAS REPORTED [THAT] AFTER THE BALLOON REACHED THE STENOSIS SITE ENDOSCOPICALLY, A LEAK WAS DETECTED WHEN INJECTING WATER, RESULTING IN FAILURE TO FILL THE BALLOON, AND THE BALLOON WAS REPLACED TO COMPLETED THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684060 ↗
• MalfunctionSep 28, 2018Crack; Use of Device Problem; Crack; Use of Device Problem

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK ECLIPSE TTC WIRE GUIDED BALLOON DILATOR. THE USER TRIED TO INFLATE THE DEVICE BUT FOUND A LEAKING ISSUE AT THE SHEATH PART [CATHETER]. THE USER RETRACTED THE DEVICE FROM THE ENDOSCOPE AND FOUND AN OBVIOUS BEND AT THE SHEATH PART. THE USER CHANGED TO ANOTHER OF THE SAME PRODUCT TO FINISH THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7918377 ↗
• MalfunctionAug 28, 2018Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK ECLIPSE TTC WIRE GUIDED BALLOON DILATOR. THE DEVICE WAS ADVANCED TO THE DESIRED POSITION WHICH WAS THE MIDDLE OF THE ESOPHAGUS. THE USER DETECTED THE PRESSURE READINGS WERE NOT CHANGING WHILE USING THE PRESSURIZATION DEVICE TO INFLATE THE BALLOON. THE USER RETRACTED THE DEVICE FROM THE ENDOSCOPE AND FOUND OUT THE BALLOON WAS LEAKING. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7823742 ↗
• MalfunctionJul 21, 2017Leak/Splash; Leak/Splash

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK ECLIPSE TTC WIRE GUIDED BALLOON DILATOR. THE USER ADVANCED DEVICE ALONG WIRE GUIDE INTO THE MIDDLE SECTION OF THE ESOPHAGUS AND BEGAN TO INFLATE IT. THE BALLOON FAILED TO INFLATE. THE BALLOON WAS FOUND LEAKING UNDER ENDOSCOPIC VISUALIZATION. THE USER WITHDREW THE DEVICE AND REPLACED IT WITH A NEW ONE TO FINISH THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6731348 ↗
• MalfunctionJan 3, 2017Hole In Material; Off-Label Use; Use of Device Problem; Hole In Material; Off-Label Use; Use of Device Problem

  DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK ECLIPSE TTC WIRE GUIDED BALLOON DILATOR. THE REPORTER STATED THAT THE BALLOON RUPTURED WHEN THEY ADVANCED THE DEVICE INTO THE DUODENAL PAPILLA [ABNORMAL USE]. THERE WERE NO ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6219759 ↗