Quantum TTC G31511Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002315112), received between Jul 11, 2016 and May 23, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  DURING AN ENDOSCOPIC PROCEDURE IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. IT WAS REPORTED THAT THE BALLOON BURST MID INFLATION. IT HAD NOT REACHED FULL DILATION YET. 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 22078444 ↗
• MalfunctionOct 21, 2019Burst Container or Vessel; Use of Device Problem; Burst Container or Vessel; Use of Device Problem

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THEY ADVANCED BALLOON DOWN INTO PATIENT. THEY INFLATED THE BALLOON TO 40 PSI. IT POPPED AT 40 PSI. 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 9216032 ↗
• MalfunctionSep 19, 2019Fluid/Blood Leak; Material Puncture/Hole; Use of Device Problem; Fluid/Blood Leak; Material Puncture/Hole; Use of Device Problem

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THE DEVICE POPPED DURING USE. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SPECIALIST ON 29 AUG 2019: "IT SOUNDS LIKE THEY WERE FILLING THE BALLOON UP, WHEN THE LUER CONNECTION BETWEEN THE BALLOON AND THE DILATION SYRINGE DISCONNECTED. AFTER RECONNECTING THE TWO, THEY PROCEEDED TO INFLATE THE BALLOON BUT WHEN IT GOT TO 40 PSI, THE BALLOON POPPED." 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 9088073 ↗
• MalfunctionJan 2, 2019Material Puncture/Hole; Material Puncture/Hole

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THE PHYSICIAN OPENED THE BALLOON PACKAGE, HOOKED IT [THE DILATION BALLOON] TO THE SYRINGE, WENT TO PUT NEGATIVE PRESSURE AND IT WOULD NOT HOLD NEGATIVE PRESSURE. IT WAS FOUND TO HAVE A HOLE [IN THE DILATION BALLOON]. THIS WAS BEFORE INSERTING IT [THE BALLOON] INTO THE ENDOSCOPE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8209442 ↗
• InjuryMay 14, 2018Burst Container or Vessel; Material Fragmentation; Use of Device Problem; Burst Container or Vessel; Material Fragmentation; Use of Device Problem

  THE FOLLOWING WAS REPORTED ON 05/14/2018 TO THE FDA: "PER MEDWATCH FORM (3302260000-2018-8003) "DURING THE PROCEDURE, THE ESOPHAGEAL BALLOON DILATOR POPPED WHILE IN THE PROCESS OF STAGE 2 INFLATION (FROM 60 PSI TO 90 PSI). IT WAS NOTICED AND IMMEDIATELY REMOVED FROM THE PATIENT WITHOUT DIFFICULTY. THERE WAS NO HARM TO THE PATIENT WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: GASTROSCOPY ESOPHAGEAL BALLOON DILATATION". (THE MEDWATCH FORM INDICATED THAT THIS EVENT OCCURRED IN (B)(6) 2018. THE EXACT DATE IS UNKNOWN.)" A PHOTO WAS RECEIVED ON 05/14/2018 THAT DEPICTED THE TIP OF A BALLOON THAT WAS SEPARATED FROM THE REST OF THE DEVICE. THE FOLLOWING WAS RECEIVED ON 05/17/2018 FROM A NURSE REGARDING THE DETACHED PORTION: ¿THE TIP WAS RETRIEVED FROM THE PATIENT AFTER EQUIPMENT FAILURE. IT FELL OFF WHEN THE BALLOON POPPED. THE TIP WAS RETRIEVED WITH A SNARE.¿ IN ADDITION, IT WAS DETERMINED THAT IT WAS UNKNOWN IF NEGATIVE PRESSURE AND LUBRICATION HAD BEEN APPLIED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 7512695 ↗
• MalfunctionApr 16, 2018Break

  DURING THE PROCEDURE THE ESOPHAGEAL BALLOON DILATOR POPPED WHILE IN PROCESS OF STAGE 2 INFLATION (FROM 60 PSI TO 90 PSI. IT WAS NOTICED AND IMMEDIATELY REMOVED FROM THE PATIENT WITHOUT DIFFICULTY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7432354 ↗
• MalfunctionFeb 13, 2018Leak/Splash; Leak/Splash

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THE BALLOON WAS NOT HOLDING WATER PRESSURE APPROPRIATELY, AND BEGAN TO LEAK AT THE PROXIMAL END OF THE BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER BALLOON OF THE SAME TYPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7266273 ↗
• MalfunctionSep 30, 2016Burst Container or Vessel; Burst Container or Vessel

  DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. DURING THE INFLATING PROCESS, THE BALLOON EXPLODED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5990909 ↗
• MalfunctionSep 2, 2016Leak/Splash; Leak/Splash

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THE BALLOON LEAKED DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5924474 ↗
• MalfunctionJul 11, 2016Burst Container or Vessel; Use of Device Problem; Burst Container or Vessel; Use of Device Problem

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THE BALLOON WAS INFLATED, HELD FOR ONE (1) MINUTE, AND THEN THE BALLOON RUPTURED WHILE INSIDE THE PATIENT. THE TIP OF THE DEVICE WAS NOTED TO BE SEPARATED BUT THE ENTIRE DEVICE CAME OUT WHEN REMOVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5782167 ↗