Hercules G31928Recalls & reported problems
Cook Incorporated · Hercules 3 Stage Balloon Esophageal · Class 2
All models of Hercules (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002319288), received between Sep 15, 2016 and Sep 15, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Hole In Material” (1 report).
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
Device problems
- Hole In Material1
- Use of Device Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2016Hole In Material; Use of Device Problem; Hole In Material; Use of Device Problem
DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. AS REPORTED TO CUSTOMER RELATIONS: "THE CUSTOMER ATTEMPTED TO ADVANCE A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL DOWN THE ENDOSCOPE AND THE DEVICE WOULD NOT GO [ADVANCE]. THEN, THE CUSTOMER USED A HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC AND THE BALLOON BURST. SEE MDR REPORT NUMBER 1037905-2016-00351. THERE WAS NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO EITHER OCCURRENCE." THE DEVICE THAT WAS REPORTED TO BE UNABLE TO BE ADVANCED, WAS RECEIVED FOR EVALUATION ON 08/24/2016. AT THIS TIME, WATER WAS NOTICED TO BE LEAKING FROM A PINHOLE IN THE BALLOON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5953686 ↗
Other Dilator, esophageal devices
- CRE Fixed Wire M00558380Boston Scientific Corporation · Dilator, esophageal359 reports
- CRE Fixed Wire M00558370Boston Scientific Corporation · Dilator, esophageal219 reports
- XXL™ Esophageal M001145590Boston Scientific Corporation · Dilator, esophageal116 reports
- Olympus BD-400P-2080Gyrus ACMI, LLC · Dilator, esophageal1 recall60 reports
- CRE Wireguided M00558500Boston Scientific Corporation · Dilator, esophageal1 recall58 reports
- Olympus BD-400P-1580Gyrus ACMI, LLC · Dilator, esophageal2 recalls4 reports
- XXL™ Esophageal M001145520Boston Scientific Corporation · Dilator, esophageal102 reports
- EZDilate BD-410X-1055Gyrus ACMI, LLC · Dilator, esophageal2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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