Hercules G31926Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00827002319264), received between Apr 26, 2016 and Aug 13, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ESOPHAGEAL ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. IT WAS REPORTED [THAT] ONCE IN THE PATIENT, THE BALLOON HAD A LEAK AND WOULD [NOT] INFLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. 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 22793601 ↗
• MalfunctionJun 23, 2025Loss of or Failure to Bond; Fluid/Blood Leak; Loss of or Failure to Bond; Fluid/Blood Leak

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. IT WAS REPORTED [THAT] THE BALLOON DID NOT INFLATE INSIDE THE PATIENT SO THEY TOOK THE BALLOON OUT OF PATIENT AND OUT OF ENDOSCOPE AND TRIED TO INFLATE IT. IT WORKED PERFECTLY SO THEY WENT BACK INSIDE THE PATIENT, BUT IT DID NOT WORK AGAIN. THEY STOPPED THE PROCEDURE. THE BALLOON WAS PERFORATED. 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 22306816 ↗
• MalfunctionMar 28, 2025Material Puncture/Hole; Material Puncture/Hole

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE IN THE LOWER ESOPHAGUS, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. IT WAS REPORTED THAT THE BALLOON WOULD NOT INFLATE. THERE WAS NO 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 21719958 ↗
• MalfunctionApr 12, 2019Material Puncture/Hole; Use of Device Problem; Material Puncture/Hole; Use of Device Problem

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED TWO (2) COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE CUSTOMER CONFIRMED A PIN HOLE IN THE BALLOON MATERIAL IN BOTH OF THE HBD-12-13.5-15S, WITH THE SAME LOT. [FOR THE] FIRST DEVICE, THE USER INFLATED THE BALLOON IN THE STENOSED SITE IN THE ESOPHAGUS. THE BALLOON COULD BE INFLATED ONCE BUT DEFLATED AS WATER LEAKED FROM A PIN HOLE. [FOR THE] SECOND DEVICE, THE PACKAGE WAS OPENED AS A REPLACEMENT OF THE FIRST DEVICE. THE USER KNEW THAT PRE-INFLATION WAS NOT SUGGESTED, BUT HE SUSPECTED THIS BALLOON HAD A PIN HOLE AS WELL, BECAUSE IT IS THE SAME LOT AS THE FIRST DEVICE. [THE USER] INFLATED THE BALLOON PRIOR TO INSERTION INTO THE ENDOSCOPE. THE BALLOON INFLATED ONCE BUT A LEAK FROM A PIN HOLE IN THE BALLOON MATERIAL WAS CONFIRMED. ANOTHER HBD-12-13.5-15 (LOT UNKNOWN) WAS USED TO COMPLETE THE PROCEDURE. FOR THE FIRST DEVICE, 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. FOR THE SECOND DEVICE, THIS OCCURRED PRIOR TO PATIEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8510342 ↗
• MalfunctionAug 7, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. [THE] HERCULES BALLOON RUPTURED WHILE IN THE PATIENT DURING THE PROCEDURE. HE [THE CHARGE NURSE] DID NOT REMEMBER ANY DETAILS ABOUT THE CASE OTHER THAN THE PATIENT WAS NOT HARMED, AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER BALLOON WITH NO PROBLEM. 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 7758492 ↗
• MalfunctionMar 29, 2018Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  DURING AN UPPER ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. ONCE THE BALLOON WAS INFLATED, IT WAS NOTED THAT IT WAS LEAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7381246 ↗
• MalfunctionMar 23, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING A DILATION PROCEDURE, [THE PHYSICIAN] USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE PHYSICIAN PERFORMED THE DILATATION WITHOUT AN ISSUE. HE THEN COMPLETELY EMPTIED THE BALLOON AND TRIED TO PULL IT OUT THROUGH THE SCOPE. ON DOING THIS, THE BALLOON TORE ALONG THE SIDE RATHER THAN COMING SMOOTHLY THROUGH THE ENDOSCOPE. ON THIS OCCASION, HE WONDERED IF THE SCOPE CAUSED THE DAMAGE TO THE BALLOON RATHER THAN IT BE A BALLOON ISSUE, AS IT TORE SIGNIFICANTLY DOWN THE SIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7367684 ↗
• MalfunctionFeb 23, 2018Leak/Splash; Leak/Splash

  IN PREPARATION FOR A DILATION PROCEDURE, THE PHYSICIAN CHOSE A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE PRODUCT WAS FOUND TO HAVE A BALLOON LEAK BEFORE THE [PROCEDURE STARTED]. THE HERCULES BALLOON WAS LEAKING AT THE MIDDLE OF THE BALLOON.

  Patient problems: No Patient Involvement

  MAUDE report 7293749 ↗
• MalfunctionNov 10, 2017Hole In Material; Leak/Splash; Improper or Incorrect Procedure or Method; Hole In Material; Leak/Splash; Improper or Incorrect Procedure or Method

  IN PREPARATION FOR A PROCEDURE, THE PHYSICIAN CHOSE A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. PRIOR TO PATIENT CONTACT, THE USER ATTEMPTED TO INFLATE THE BALLOON TO CHECK IF THE BALLOON WOULD INFLATE PROPERLY. HOWEVER THE BALLOON WOULD NOT INFLATE AND THE USER FOUND THE INJECTED SALINE WAS LEAKING FROM THE BALLOON. HE REPLACED IT WITH ANOTHER HBD-12-13.5-15 [COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL] TO COMPLETE THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 7022619 ↗
• MalfunctionNov 22, 2016Burst Container or Vessel; Burst Container or Vessel

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. UPON INFLATING THE BALLOON, THE BALLOON POPPED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6120602 ↗
• MalfunctionOct 25, 2016Hole In Material; Hole In Material

  DURING AN ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE USER ADDED SIX (6) ATM OF PRESSURE TO INFLATE THE BALLOON TO FIFTEEN (15) MM, FOLLOWING TWELVE (12) MM, AND 13.5 MM, BUT THE BALLOON WOULD NOT INFLATE. HE [THE PHYSICIAN] DEFLATED ONCE AND ATTEMPTED TO INFLATE AGAIN, BUT CONFIRMED THE BALLOON WOULD NOT INFLATE DUE TO LEAK FROM A PINHOLE. ANOTHER HERCULES 3 STAGE BALLOON ESOPHAGEAL WAS USED INSTEAD TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6053429 ↗
• MalfunctionSep 30, 2016Hole In Material; Hole In Material

  DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. AS REPORTED TO COOK CUSTOMER RELATIONS: "THE BALLOON RUPTURED AT THE LAST STAGE OF INFLATION."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5989904 ↗
• MalfunctionSep 6, 2016Burst Container or Vessel; Burst Container or Vessel

  DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON BURST IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5930646 ↗
• MalfunctionApr 26, 2016Hole In Material; Hole In Material

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THEY WERE INFLATING RIGHT UP TO THE FIFTEEN (15) MM SIZE OF THE BALLOON. JUST BEFORE THEY REACHED THAT SIZE, FIFTEEN (15) MM, THE TENSION IN THE HANDLE RELEASED AND IT WOULD NOT INFLATE OR DEFLATE. THEY REMOVED THE BALLOON AND NOTICED A HOLE. THE BALLOON DID NOT BURST. THEY FINISHED THE PROCEDURE WITH TWO ADDITIONAL DILATION BALLOONS. THE EVENT INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5608947 ↗