Quantum TTC G22312Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002223127), received between Sep 16, 2016 and Sep 29, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941354 ↗
• MalfunctionMar 31, 2023Inflation Problem; Material Integrity Problem

  BALLOON POPPED DURING INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16655050 ↗
• MalfunctionApr 4, 2019Burst Container or Vessel; Burst Container or Vessel

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. DURING THE PREPARATION, THE TECHNICIAN WAS APPLYING NEGATIVE PRESSURE AND IT WAS NOT HOLDING. HE THEN INFLATED IT TO SEE WHAT WAS GOING ON AND THERE WAS A TEAR IN IT. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8484678 ↗
• MalfunctionFeb 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH BALLOON DILATION PROCEDURE, THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THE PHYSICIAN ADVANCED THE BALLOON OUT OF THE ENDOSCOPE AND WHEN THEY STARTED TO INFLATE THE BALLOON, IT STARTED TO LEAK WATER. THE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER OF THE SAME DEVICE TYPE WAS USED TO CONTINUE THE PROCEDURE WITH NO FURTHER ISSUES. 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 8342815 ↗
• MalfunctionJun 20, 2017Burst Container or Vessel; Burst Container or Vessel

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. AS THEY STARTED TO INFLATE, THE BALLOON "RIPPED OPEN AND POPPED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6654409 ↗
• MalfunctionJun 16, 2017Hole In Material; Use of Device Problem; Hole In Material; Use of Device Problem

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THE USER OPERATED THE CANNULATION [INTUBATION] SUCCESSFULLY AND BEGAN TO PLACE THE DEVICE. THEY ADVANCED THE DEVICE ALONG THE ENDOSCOPE CHANNEL AND BEGAN TO INJECT THE BALLOON, BUT THE DEVICE COULD NOT BE INFLATED. THEY WITHDREW THE DEVICE AND THE BALLOON WAS FOUND TO BE LEAKING. THEY REPLACED THE BALLOON WITH A NEW DEVICE TO FINISH THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6648596 ↗
• MalfunctionSep 16, 2016Burst Container or Vessel; Burst Container or Vessel

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. AS REPORTED TO CUSTOMER RELATIONS: "THE BALLOON WAS ADVANCED THROUGH THE ENDOSCOPE. WHEN THE MAXIMUM DILATION WAS REACHED, THE BALLOON BURST. THEY REMOVED THE DEVICE FULLY INTACT AND USED ANOTHER DEVICE WITH A DIFFERENT LOT NUMBER TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT AND NOTHING DETACHED INSIDE OF THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5955555 ↗