Eclipse G25631Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002256316), received between Nov 15, 2016 and Apr 27, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Material Puncture/Hole

  DURING AN ESOPHAGEAL STRICTURE DILATION THE PHYSICIAN USED A COOK ECLIPSE TTC WIRE GUIDED BALLOON DILATOR. IT WAS REPORTED THAT THE USER INFLATED THE BALLOON WITH WATER AND DISCOVERED THE 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 25003685 ↗
• MalfunctionApr 3, 2026Material Puncture/Hole

  DURING AN ESOPHAGEAL STRICTURE DILATION THE PHYSICIAN USED A COOK ECLIPSE TTC WIRE GUIDED BALLOON DILATOR. IT WAS REPORTED THAT THE BALLOON LEAKED. THE USER CHANGED TO ANOTHER OF THE SAME DEVICE TO CONTINUE 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 24782439 ↗
• MalfunctionJan 8, 2026Material Puncture/Hole

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK ECLIPSE TTC WIRE GUIDED BALLOON DILATOR. IT WAS REPORTED [THAT] THE USER DETECTED THE BALLOON LEAKING DURING PRE-INFLATION [PRIOR TO USE]. USER CHANGED TO A NEW DEVICE TO COMPLETE THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24002634 ↗
• MalfunctionJun 9, 2025Off-Label Use; Off-Label Use

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) TO DILATE THE STRICT DUODENAL PAPILLA, THE PHYSICIAN USED A COOK ECLIPSE TTC WIRE GUIDED BALLOON DILATOR. IT WAS REPORTED [THAT] DURING THE PROCESS OF INJECTING FLUID TO FILL THE BALLOON, IT WAS FOUND THAT THE BALLOON COULD NOT BE INFLATED, AND THE INJECTION FLUID LEAKED OUT FROM THE MIDDLE PART OF THE BALLOON AFTER OBSERVATION. A BREAK WAS FOUND IN THE MIDDLE AND UPPER PART OF THE BALLOON. THE [BALLOON] CATHETER WAS IMMEDIATELY REPLACED WITH A NEW BALLOON CATHETER AND THE PROCEDURE WENT SMOOTHLY WITHOUT ANY ADVERSE REACTION. 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 22170338 ↗
• MalfunctionNov 15, 2016Leak/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 USER SAID THAT THE BALLOON WAS LEAKING DURING THE PROCEDURE. THE FAULTY DEVICE WAS REPLACED WITH A NEW ONE TO FINISH IT [THE PROCEDURE]. SEE RELATED MDR REPORT NUMBER 1037905-2016-00461.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6103325 ↗
• MalfunctionNov 15, 2016Leak/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 USER SAID THAT THE BALLOON WAS LEAKING DURING THE PROCEDURE. THE FAULTY DEVICE WAS REPLACED WITH A NEW ONE TO FINISH IT [THE PROCEDURE]. SEE RELATED MDR REPORT NUMBER 1037905-2016-00462.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6103322 ↗