Hercules G51799Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00827002517998), received between Jul 28, 2016 and May 27, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Hole In Material” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Fracture

  DURING AN DUODENAL DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT AFTER OPENING THE PACKAGE NORMALLY AND APPLYING LUBRICATION TO THE BALLOON AFTER NEGATIVE PRESSURE SUCTION, THE BALLOON WAS INSERTED INTO THE ENDOSCOPE WORKING CHANNEL AND INFLATED FOR DILATION. HOWEVER, LEAKAGE ISSUE WAS DISCOVERED, PREVENTING THE BALLOON FROM BEING FULLY INFLATED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 01MAY2026 AND IT WAS DETERMINED THAT THE CATHETER WAS LEAKING FROM A BREAK/KINK AT 96CM FROM THE HUB WHEN ATTEMPTING TO INFLATE THE BALLOON [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 25303318 ↗
• MalfunctionApr 1, 2026Fluid/Blood Leak

  DURING AN ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT THE BALLOON FAILED TO INFLATE AS THERE APPEARED TO BE A LEAK. PHYSICIAN USED ANOTHER [UNKNOWN] BALLOON TO COMPLETE 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 24755767 ↗
• MalfunctionMar 25, 2026Material Puncture/Hole

  DURING AN UPPER ENDOSCOPIC DILATION PROCEDURE IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT THERE WAS A LEAK IN THE DISTAL END OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER COOK [HBD-W-10-11-12] DILATION BALLOON. 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 24687855 ↗
• MalfunctionMar 2, 2026Fracture

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT THE BALLOON CATHETER WAS DAMAGED, MAKING IT IMPOSSIBLE TO INFLATE THE MATERIAL. THE PROCEDURE NEEDED TO BE RESCHEDULED. CUSTOMER PROVIDED PHOTOS. THE PHOTOS SHOW THE PROXIMAL END OF THE DEVICE AND A SECTION OF THE CATHETER, AND THE CATHETER APPEARS TO BE BROKEN. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482732 ↗
• MalfunctionNov 5, 2025Off-Label Use; Off-Label Use

  DURING A STONE REMOVE PROCEDURE IN THE BILE DUCT, THE USER SELECTED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] USER ADVANCED THE BALLOON DEVICE THROUGH ENDOSCOPE WORKING CHANNEL TO STENOSIS AREA TO DILATE WHILE FINDING OUT THE LEAKING ISSUE. USER CHANGED TO ANOTHER DEVICE TO CONTINUE THE PROCEDURE. AN IMAGE OF THE DEVICE SHOWING THE BALLOON DEFLATED WAS PROVIDED. 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 23480075 ↗
• MalfunctionAug 21, 2025Fracture; Fracture

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE MATERIAL WAS DAMAGED WITH A FOLD IN THE MEDIAL REGION WHERE A CRACK WAS FOUND, MAKING IT IMPOSSIBLE TO USE. CUSTOMER PROVIDES PICTURES THAT SHOWS CATHETER BREAKAGE AND A CUT OFF BALLOON AT THE DISTAL END OF DEVICE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22862150 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT THE LEAKED CONTRAST INTO THE STOMACH WHILE DILATING [IN THE ESOPHAGUS]. 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 22204683 ↗
• MalfunctionFeb 5, 2025Fracture; Fracture

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] DURING THE PROCEDURE, THE STAFF FELT SOMETHING SNAP. ON FURTHER EXAMINATION IT WAS NOTICED THE OUTER SHEATH WAS BROKEN/SNAPPED. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312238 ↗
• MalfunctionNov 8, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. WHEN FILLING THE BALLOON WITH WATER, IT WAS FOUND TO BE PUNCTURED, MAKING IT IMPOSSIBLE TO COMPLETELY FILL AND PERFORM THE PROCEDURE WITH THIS MATERIAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DILATION BALLOON. 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 9297532 ↗
• MalfunctionJun 21, 2019Fluid/Blood Leak; Use of Device Problem; Fluid/Blood Leak; Use of Device Problem

  THIS CORRECTION FOLLOW UP REPORT IS BEING SENT TO CANCEL THE INITIAL REPORT SUBMITTED RELATED TO THIS EVENT. PLEASE REFERENCE THE SECTION H10 ADDITIONAL MANUFACTURER NARRATIVE FOR THIS JUSTIFICATION.

  Patient problems: No Patient Involvement

  MAUDE report 8722110 ↗
• MalfunctionMay 17, 2019Crack; Use of Device Problem; Crack; Use of Device Problem

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE USER ADVANCED THE DEVICE INTO THE ENDOSCOPE AND FOUND THAT THE CATHETER WAS BROKEN. THE USER DID NOT DILATE [INFLATE] THE BALLOON AND RETRACTED THE DEVICE IMMEDIATELY. THE USER CHANGED TO ANOTHER [OF THE] SAME DEVICE TO COMPLETE 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 8620403 ↗
• MalfunctionMay 10, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  DURING AN UPPER ENDOSCOPY WITH DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. WHEN THE PHYSICIAN WAS DILATING, THE CATHETER RIPPED [CRACKED] AND WATER CAME OUT. THE DEVICE WAS REMOVED INTACT. NOTHING DETACHED INSIDE OF THE PATIENT. NO OTHER DEVICE WAS USED AS THIS WAS THE END OF 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 8600759 ↗
• MalfunctionMar 7, 2019Crack; Use of Device Problem; Crack; Use of Device Problem

  DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. [THE USER] HAD DIFFICULTY GETTING THE BALLOON TO EXIT THE ENDOSCOPE TO PASS THROUGH THE STRICTURE, WHICH CAUSED THE DEVICE TO KINK. TO FINISH THE PROCEDURE, A [COMPETITOR'S] WIRE GUIDED BALLOON [WAS USED] AND THEN FOLLOWED THAT WITH ANOTHER COOK DILATION BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 12-FEB-2019 AND WAS FOUND TO HAVE A CRACK IN THE CATHETER. 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 8398666 ↗
• MalfunctionNov 6, 2018Crack; Crack

  IN PREPARATION FOR A PROCEDURE, THE PHYSICIAN CHOSE A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC (HBD-W). THE CATHETER WAS KINKED IN SEVERAL PLACES AS THE CUSTOMER OPENED THE PACKAGING. THEY USED A DIFFERENT HBD-W WITHOUT ANY PROBLEMS. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 12-OCT-2018 AND WAS FOUND TO HAVE MULTIPLE CRACKS IN THE BLUE CATHETER. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8043293 ↗
• MalfunctionMar 29, 2018Crack; Crack

  IN PREPARATION FOR A PROCEDURE, THE USER CHOSE A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE OPERATOR OBSERVED THE OUTER SHEATH [CATHETER] WAS BROKEN BEFORE ADVANCING IT INTO THE ENDOSCOPE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7381563 ↗
• MalfunctionFeb 20, 2018Crack; Crack

  IN PREPARATION FOR A DILATION PROCEDURE, THE PHYSICIAN CHOSE A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE DEVICE WAS DAMAGED WITHIN THE PACKAGING AS IF IT WAS CUT. ACCORDING TO THE COMPLAINT FORM RECEIVED (B)(6) 2018: AFTER UNPACKING THE BALLOON, THEY REALIZED THAT THE CATHETER WAS CRACKED RIGHT ABOVE THE SILVER MARKER.

  Patient problems: No Patient Involvement

  MAUDE report 7283712 ↗
• MalfunctionFeb 9, 2018Hole In Material; Leak/Splash; Improper or Incorrect Procedure or Method; Hole In Material; Leak/Splash; Improper or Incorrect Procedure or Method

  DURING A DILATION PROCEDURE, THE PHYSICIAN CHOSE THREE (3) COOK HERCULES 3 STAGE WIREGUIDED BALLOONS ESOPHAGEAL-PYLORIC-COLONIC FROM THE SAME LOT. EACH OF THE THREE (3) BALLOONS POPPED DURING THIS PROCEDURE. THEY WERE ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7260894 ↗
• MalfunctionNov 21, 2017Leak/Splash; Off-Label Use; Leak/Splash; Off-Label Use

  DURING AN ESOPHAGEAL DILATION ON A PEDIATRIC PATIENT, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE USER NOTED THAT CONTRAST WAS LEAKING FROM THE DISTAL END OF THE BALLOON. THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7050584 ↗
• MalfunctionNov 21, 2017Leak/Splash; Off-Label Use; Leak/Splash; Off-Label Use

  DURING AN ESOPHAGEAL DILATION ON A PEDIATRIC PATIENT, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE USER NOTED THAT CONTRAST WAS LEAKING FROM THE DISTAL END OF THE BALLOON. THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7050566 ↗
• MalfunctionNov 21, 2017Leak/Splash; Off-Label Use; Leak/Splash; Off-Label Use

  DURING AN ESOPHAGEAL DILATION ON A PEDIATRIC PATIENT, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE USER NOTED THAT CONTRAST WAS LEAKING FROM THE DISTAL END OF THE BALLOON. THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7050563 ↗
• MalfunctionOct 23, 2017Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON. THE PHYSICIAN FOUND THE BALLOON BROKEN BEFORE USING IT IN THE PATIENT. HE COULD NOT INFLATE THE BALLOON. A REPLACEMENT BALLOON WAS USED TO SUCCESSFULLY FINISH THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 6969832 ↗
• MalfunctionAug 25, 2017Crack; Use of Device Problem; Crack; Use of Device Problem

  DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THEY TOOK THE STYLET OUT, AND WERE TRYING TO INFLATE THROUGH THE STYLET OPENING INSTEAD OF THE INFLATION PORT. WHEN THEY PLACED THE BALLOON DOWN THE ENDOSCOPE, IT WOULD NOT INFLATE. THE COOK SALES REPRESENTATIVE WILL BE DOING AN IN-SERVICE. ANOTHER DEVICE WAS USED FOR THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 07/31/2017. THE DEVICE WAS FOUND TO HAVE A CRACKED CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6819887 ↗
• MalfunctionJul 27, 2017Hole In Material; Off-Label Use; Use of Device Problem; Hole In Material; Off-Label Use; Use of Device Problem

  DURING A PAPILLARY DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC [AGAINST INTENDED USE]. THE USER INJECTED THE CONTRAST INTO THE DEVICE AND THE BALLOON WAS FOUND TO BE LEAKING. THEY WITHDREW THE DEVICE AND REPLACED IT WITH A NEW ONE TO FINISH THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6746453 ↗
• MalfunctionJun 23, 2017Hole In Material; Hole In Material

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THERE WAS A HOLE IN DISTAL END OF BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6664021 ↗
• MalfunctionJun 20, 2017Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIRE-GUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE USER COULD NOT INFLATE OR DEFLATE THE BALLOON. THE BALLOON WAS LEAKING. THEY REPLACED THE BALLOON WITH A NEW BALLOON TO FINISH THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6655080 ↗