Hercules G31925Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002319257), received between Apr 26, 2016 and Mar 28, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2025Material Puncture/Hole; Material Puncture/Hole

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. IT WAS REPORTED [THAT] THE BALLOON WOULD NOT INFLATE ONCE DOWN THE SCOPE. THERE WAS NOT REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 05MAR2025 AND IT WAS DETERMINED THAT THE BALLOON LEAKED AT THE DISTAL END [SUBJECT OF REPORT]. 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 21720443 ↗
• MalfunctionSep 17, 2019Fluid/Blood Leak; Use of Device Problem; Fluid/Blood Leak; Use of Device Problem

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. AS THE BALLOON WAS INFLATED, LEAKAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER HBD-10-11-12. 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 9078377 ↗
• MalfunctionOct 24, 2016Burst Container or Vessel; Burst Container or Vessel

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH BALLOON DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE PHYSICIAN WAS INFLATING THE BALLOON (IT IS UNCLEAR HOW FAR IT WAS INFLATED), THE TECHNICIAN BELIEVES IT WAS OVER INFLATED. THE BALLOON POPPED AND PIECES OF THE BALLOON REMAINED IN THE PATIENT. THE PHYSICIAN STATED THE PIECES WOULD PASS NATURALLY AND THEY WERE LEFT IN THE PATIENT.

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

  MAUDE report 6050618 ↗
• MalfunctionApr 26, 2016Hole In Material; Use of Device Problem; Hole In Material; Use of Device Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATES THAT DURING AN ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL TO TREAT AN ESOPHAGEAL STENOSIS. AT THE SECOND ATTEMPT OF ESOPHAGEAL DILATION WITH THE DEVICE, THE BALLOON STOPPED INFLATING AT A CERTAIN PRESSURE. THE PHYSICIAN REMOVED THE DEVICE FROM THE ENDOSCOPE TO INSPECT THE DEVICE VISUALLY, THE PHYSICIAN THEN NOTICED LEAKAGE OF SALINE. THE FIRST DILATION SUCCEEDED; HOWEVER, THE PHYSICIAN ACTUALLY WANTED TO DILATE THE LESION TWICE WITH THE DEVICE. SINCE THE SECOND DILATION FAILED DUE TO DAMAGE OF THE DEVICE, THE SECOND DILATION WILL BE CONDUCTED AT A LATER DATE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5609567 ↗