Quantum TTC G22313Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002223134), received between Apr 28, 2016 and Nov 11, 2019 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2019Burst Container or Vessel; Use of Device Problem; Burst Container or Vessel; Use of Device Problem

  DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THE BALLOON POPPED. THE PRESSURE OF THE BALLOON WHEN IT POPPED IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. 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 9307086 ↗
• MalfunctionAug 29, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THE BALLOON WAS INFLATED WITH WATER TO MAXIMUM PRESSURE PER THE INSTRUCTIONS FOR USE (IFU). THE MEDICAL STAFF WAS TRYING FOR A FULL MINUTE OF DILATION; HOWEVER, AFTER APPROXIMATELY 40 SECONDS, THE BALLOON BURST. 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 8946041 ↗
• MalfunctionAug 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. WHEN STARTING TO INFLATE THE BALLOON USING WATER, THE BALLOON LEAKED AND WOULD NOT INFLATE. THIS BALLOON WAS REMOVED WITHOUT INCIDENT AND ANOTHER BALLOON WAS USED 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 8946039 ↗
• MalfunctionAug 12, 2019Burst Container or Vessel; Use of Device Problem; Burst Container or Vessel; Use of Device Problem

  THE FOLLOWING WAS REPORTED TO THE FDA ON 12-AUG-2019, "DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED TWO (2) COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATORS. TWO (2) BALLOONS POPPED DURING THE SAME PROCEDURE. TWO (2) EMPLOYEES HAD TO LEAVE OTHER PROCEDURES TO GO TO ANOTHER SITE TO RETRIEVE MORE BALLOON DILATORS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. ADDITIONAL INFORMATION PROVIDED STATED THAT THE DEVICE WAS INFLATED TO 6-8 ATMOSPHERES, WHICH IS BEYOND THE MAXIMUM LABELED INFLATION PRESSURE FOR THIS DEVICE." ADDITIONAL INFORMATION WAS RECEIVED ON 14-AUG-2019: THE USER STATED THEY DID NOT INFLATE OVER 3.5 ATM AS THE COMPLAINT REPORT INDICATES. THE COOK REPRESENTATIVE BELIEVE WHOEVER FIELDED THIS COMPLAINT MISUNDERSTOOD WHAT THE CUSTOMER WAS SAYING OR THERE WAS SOME CONFUSION GOING ON. SHE INDICATED THE BALLOONS POPPED AT OR BELOW THE 3.5 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 Consequences Or Impact To Patient

  MAUDE report 8885814 ↗
• MalfunctionJun 10, 2019Burst Container or Vessel; Use of Device Problem; Burst Container or Vessel; Use of Device Problem

  DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THE BALLOON BURST AT 2.5 ATM DURING THE FIRST INFLATION. 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 Consequences Or Impact To Patient

  MAUDE report 8684719 ↗
• MalfunctionMay 24, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING AN ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THE BALLOON POPPED BEFORE REACHING 40 PSI. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8640446 ↗
• MalfunctionMay 24, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING AN ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THE BALLOON POPPED BEFORE REACHING 40 PSI. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8640445 ↗
• MalfunctionFeb 11, 2019Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THE BALLOON POPPED DURING THE PROCEDURE (DURING DILATION). ADDITIONAL INFORMATION PROVIDED BY THE COOK SALES REPRESENTATIVE ON 22-JAN-2019: PER THE TECHNICIAN, WHEN THEY STARTED TO INFLATE THE BALLOON THEY GOT IT HALFWAY INFLATED AND THE BALLOON STARTED TO LEAK (MORE LIKE A PINHOLE). THE PATIENT'S ESOPHAGUS STARTED TO FILL WITH WATER INSTEAD OF THE BALLOON, MORE OF A SLOW LEAK (BUT NOT TOO SLOW). 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 8325267 ↗
• MalfunctionJan 15, 2019Fluid/Blood Leak; Material Puncture/Hole; Use of Device Problem; Fluid/Blood Leak; Material Puncture/Hole; Use of Device Problem

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. WHEN THE DEVICE BEGAN INFLATING, IT REACHED AROUND 4 ATM (ATMOSPHERE); AT THIS POINT, A PINHOLE LEAK WAS NOTICED. THE DEVICE WAS REMOVED AND ANOTHER OF THE SAME DEVICE WAS USED 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 8249897 ↗
• MalfunctionFeb 24, 2017Burst Container or Vessel; Burst Container or Vessel

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THE DILATOR WAS BEING USED TO DILATE AN ESOPHAGEAL STRICTURE. AT SOME POINT DURING THE PROCEDURE, WHEN THE BALLOON WAS BEING INFLATED TO MAXIMUM PRESSURE LEVEL, THE BALLOON INTEGRITY FAILED, CAUSING STERILE WATER TO LEAK FROM THE DILATOR AND INTO THE PATIENT'S ESOPHAGUS. THE BALLOON DILATOR AND ENDOSCOPE WERE IMMEDIATELY REMOVED FROM THE PATIENT. THE ATTENDING PHYSICIAN REINSERTED THE ENDOSCOPE TO INSPECT PATIENT ESOPHAGUS AND TOOK MORE BIOPSIES WITH FORCEPS. THE DILATION OF THE STRICTURE WAS CONSIDERED A SUCCESS, AND UPON FURTHER INSPECTION OF PATIENT'S ESOPHAGUS WITH THE ENDOSCOPE, NO VISIBLE ADVERSE EFFECTS WERE OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6357210 ↗
• MalfunctionSep 30, 2016Burst Container or Vessel; Burst Container or Vessel

  DURING AN UPPER ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. UPON INFLATION TO MAXIMUM PRESSURE, THE BALLOON POPPED. THE CASE WAS COMPLETE AT THIS TIME AND THE DEVICE WAS ABLE TO BE REMOVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5989905 ↗
• MalfunctionApr 28, 2016Burst Container or Vessel; Burst Container or Vessel

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THE DEVICE WAS PASSED THROUGH THE ENDOSCOPE AND THE FACILITY WENT TO INFLATE IT, AND IT POPPED. A NEW G22313-QD-18X8 [COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR] WAS OPENED AND USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5617305 ↗