Hercules G35271Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002352711), received between Mar 2, 2021 and Apr 27, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING A TRANSORAL ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK HERCULES 100 3 STAGE WIRE GUIDED BALLOON. IT WAS REPORTED [THAT] THE BALLOON BLEW UP TO THE FIRST STAGE AT 2 ATM AND THEN THEY TOOK THE BALLOON OUT, REINSERTED AND INFLATED TO THE 2ND STAGE AT 4 ATM. THE USER STATED "THE BALLOON WAS HITTING THE TRANSORAL METAL INSERTER WHEN INFLATED (NOT SURE IF THIS IS WHAT IT'S CALLED) AND STARTED BEING UNABLE TO HOLD THE ATM". THEY DEFLATED AND TOOK OUT THE BALLOON. BLEW UP THE BALLOON OUTSIDE OF THE PATIENT AND THERE WAS A SMALL HOLE IN THE BALLOON. THE USER EXPLAINED THAT THEY THINK IT IS DUE TO THE BALLOON HITTING THE METAL INSERTER BUT FEELS THERE IS NO WAY TO BE SURE. 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 16826983 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A HERCULES 100 3 STAGE WIRE GUIDED BALLOON. THE PROCEDURE WENT AS INTENDED AND WAS COMPLETED WITH DILATION BEING COMPLETED IN THREE (3) INCREMENTAL STEPS TO ACHIEVE 20 MM OF DILATION. THE BALLOON WAS USED WITHOUT ANY DIFFICULTY AND WORKED APPROPRIATELY BOTH INFLATING AND RAPIDLY DEFLATING THROUGHOUT THE CASE. THERE WERE NOT ANY AREAS OF CONCERN THAT WERE SEEN OR DISCUSSED DURING OR POST CASE. ONE WEEK AFTER THE PROCEDURE, THE PHYSICIAN HAD A FOLLOW UP WITH THE PATIENT WHO HAD DEVELOPED SEVERE SUPRAGLOTTIC SWELLING ABOVE THE DILATION SITE. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN STATES THAT HE BELIEVED THE BALLOON WAS INFLATED WITH WATER TO THE SPECIFIED ATM FOR 20 MM OF DILATION. THERE WAS NO DIFFICULTY WITH ACCESS OR ADVANCING THE ENDOSCOPE. NO NEGATIVE PRESSURE WAS APPLIED TO THE BALLOON AND WE USED A RIGID ENDOSCOPE THROUGH THE MOUTH (NOT A FLEXIBLE ENDOSCOPE VIA A CHANNEL). NO LUBRICATION WAS USED, BUT THIS WAS NOT A CHANNELED INSERTION. THE SUPRAGLOTTIC SWELLING WAS TREATED WITH ANTIBIOTICS, STEROIDS, AND INTENSIVE CARE UNIT (ICU) OBSERVATION. AIRWAY SYMPTOMS STARTED ABOUT FIVE (5) DAYS AFTER SURGERY. PATIE

  Patient problems: Swelling/ Edema

  MAUDE report 11398455 ↗