HerculesRecalls & reported problems across all models
Cook Incorporated · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 376
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 11 models of Hercules by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 376 adverse event reports in the FDA's MAUDE database, received between Apr 26, 2016 and Sep 29, 2026 — classified as 11 injuries, 365 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (97 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Hercules problems
Device problems
- Use of Device Problem97
- Crack90
- Burst Container or Vessel77
- Fluid/Blood Leak61
- Leak/Splash55
- Hole In Material43
- Material Puncture/Hole42
- Fracture33
Patient problems
- No Consequences Or Impact To Patient264
- No Clinical Signs, Symptoms or Conditions76
- No Patient Involvement20
- No Known Impact Or Consequence To Patient14
- Foreign Body In Patient9
- Laceration(s) of Esophagus3
- Aspiration/Inhalation2
- Tissue Damage2
Hercules models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Hercules G31927Dilator, esophageal74 reports
- Hercules G51797Dilator, esophageal58 reports
- Hercules G51796Dilator, esophageal57 reports
- Hercules G51798Dilator, esophageal56 reports
- Hercules G51795Dilator, esophageal44 reports
- Hercules G48732Dilator, esophageal34 reports
- Hercules G51799Dilator, esophageal32 reports
- Hercules G31926Dilator, esophageal14 reports
- Hercules G31925Dilator, esophageal4 reports
- Hercules G35271DILATOR, ESOPHAGEAL, ENT2 reports
- Hercules G31928Dilator, esophageal1 report
Recent Hercules adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938347 ↗MalfunctionSep 24, 2026Off-Label Use
During a tracheal stenosis dilation procedure, the physician used a Cook HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. It was reported "[that]" a balloon leak was observed in the catheter, requiring a replacement during 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 50883444 ↗MalfunctionSep 16, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791822 ↗InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem
During an esophageal dilation procedure, the physician used a Cook HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. It was reported that the physician experienced an inability to feel resistance and was unable to visualize the distal end of the balloon during inflation. The dilation tear in the patient's tissue was larger than expected. It is unknown how the procedure was completed. A picture was provided showing an endoscopic view of reported "dilation tear in the patient's tissue." An additional picture shows the device in vivo and the balloon is inflated within the stricture. A section of the device did not remain inside the patient¿s body. The patient experienced a larger tear to tissue than expected. According to the initial reporter, it is unknown how the procedure was completed.
Patient problems: Laceration(s) of Esophagus
MAUDE report 50525348 ↗MalfunctionAug 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506015 ↗MalfunctionAug 25, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50438231 ↗MalfunctionAug 25, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50437868 ↗MalfunctionAug 21, 2026Fracture; Improper or Incorrect Procedure or Method
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50376273 ↗MalfunctionAug 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50372520 ↗MalfunctionAug 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50372355 ↗MalfunctionAug 12, 2026Improper or Incorrect Procedure or Method
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50227553 ↗MalfunctionAug 11, 2026Fluid/Blood Leak
During a gastrointestinal dilation procedure, the physician used a Cook HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. It was reported that there was a small hole in the balloon as it would not inflate to (b)(6) "[atm]".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 50215437 ↗MalfunctionAug 11, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213208 ↗MalfunctionAug 10, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50194917 ↗MalfunctionAug 6, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50163626 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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