Quantum TTCRecalls & reported problems across all models
Cook Incorporated · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
7 open recalls name at least one Quantum TTC model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 51
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 7
We found 14 models of Quantum TTC by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Apr 12, 2016 and Sep 29, 2026 — classified as 1 injury, 50 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (21 reports).
7 FDA recall records name at least one of these models by its device identifier, 7 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Quantum TTC recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 3, 2023Open, Classified
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Z-0463-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 3, 2023Open, Classified
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Z-0462-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 3, 2023Open, Classified
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Z-0461-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 3, 2023Open, Classified
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Z-0460-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 3, 2023Open, Classified
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Z-0459-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 3, 2023Open, Classified
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Z-0458-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 3, 2023Open, Classified
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Z-0457-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Quantum TTC problems
Device problems
- Use of Device Problem21
- Burst Container or Vessel20
- Material Puncture/Hole11
- Fluid/Blood Leak10
- Hole In Material8
- Leak/Splash4
- Off-Label Use3
- Improper or Incorrect Procedure or Method2
Patient problems
- No Consequences Or Impact To Patient42
- No Clinical Signs, Symptoms or Conditions4
- No Known Impact Or Consequence To Patient3
- No Patient Involvement2
- Foreign Body In Patient1
Quantum TTC models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Quantum TTC G22656CATHETER, BILIARY, DIAGNOSTIC1 recall9 reports
- Quantum TTC G22657CATHETER, BILIARY, DIAGNOSTIC1 recall5 reports
- Quantum TTC G22655CATHETER, BILIARY, DIAGNOSTIC1 recall3 reports
- Quantum TTC G22654CATHETER, BILIARY, DIAGNOSTIC1 recall0 reports
- Quantum TTC G22765CATHETER, BILIARY, DIAGNOSTIC1 recall0 reports
- Quantum TTC G22766CATHETER, BILIARY, DIAGNOSTIC1 recall0 reports
- Quantum TTC G22767CATHETER, BILIARY, DIAGNOSTIC1 recall0 reports
- Quantum TTC G22313Dilator, esophageal12 reports
- Quantum TTC G31511Dilator, esophageal10 reports
- Quantum TTC G22312Dilator, esophageal7 reports
- Quantum TTC G22544Dilator, esophageal2 reports
- Quantum TTC G22311Dilator, esophageal1 report
- Quantum TTC G22997Dilator, esophageal1 report
- Quantum TTC G22998Dilator, esophageal1 report
Recent Quantum TTC adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗MalfunctionMar 31, 2023Inflation Problem; Material Integrity Problem
BALLOON POPPED DURING INFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16655050 ↗MalfunctionApr 2, 2021Fluid/Blood Leak; Fluid/Blood Leak
DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED TWO (2) COOK QUANTUM TTC COLONIC BALLOON DILATORS. THE PHYSICIAN REPORTED THAT TWO (2) BALLOONS HAD HOLES IN THEM. THE PHYSICIAN USED ANOTHER OF THE SAME DEVICE 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 Clinical Signs, Symptoms or Conditions
MAUDE report 11608890 ↗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 ↗MalfunctionOct 21, 2019Material Puncture/Hole; Material Puncture/Hole
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK QUANTUM TTC BILIARY BALLOON DILATOR. THE USER ADVANCED THE DEVICE THROUGH WIRE GUIDE TO DUODENAL PAPILLA AND INFLATED THE BALLOON. THE USER FOUND A LEAKING ISSUE. THE USER RETRACTED THE DEVICE AND CHANGED ANOTHER SAME DEVICE 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 9216034 ↗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 23, 2019Material Puncture/Hole; Use of Device Problem; Material Puncture/Hole; Use of Device Problem
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK QUANTUM TTC BILIARY BALLOON DILATOR. THE USER ADVANCED THE DEVICE TO THE DESIRED POSITION AND INFLATED THE BALLOON, BUT THE BALLOON WAS NOT INFLATED AS EXPECTED. THE USER RETRACTED THE DEVICE FROM PATIENT AND FOUND OUT THAT THE BALLOON WAS BROKEN. 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 9106142 ↗MalfunctionSep 19, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR. THE USER ADVANCED THE DEVICE TO THE DESIRED POSITION AND FOUND OUT THE BALLOON WAS LEAKING. THE USER CHANGED TO ANOTHER OF THE SAME DEVICE 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 9090145 ↗MalfunctionSep 19, 2019Material Puncture/Hole; Material Puncture/Hole
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK QUANTUM TTC BILIARY BALLOON DILATOR. THE USER ADVANCED THE DEVICE TO THE DESIRED POSITION AND INFLATED THE BALLOON, BUT THE BALLOON WAS NOT INFLATED AS EXPECTED. THE USER RETRACTED THE DEVICE FROM PATIENT AND FOUND OUT THE BALLOON IS BROKEN. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ON (B)(6) 2019, IT WAS REPORTED THAT THE BALLOON WAS USED IN THE DUODENAL PAPILLA. 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 9089786 ↗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 ↗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 ↗MalfunctionJul 1, 2019Fluid/Blood Leak; Material Puncture/Hole; Use of Device Problem; Fluid/Blood Leak; Material Puncture/Hole; Use of Device Problem
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK QUANTUM TTC BILIARY BALLOON DILATOR. THE BALLOON COULD NOT BE INFLATED DURING THE PROCEDURE. THE USER RETRACTED THE DEVICE AND INFLATED IT OUTSIDE OF THE PATIENT [WHICH IS WHEN THEY] FOUND OUT THERE WAS A LEAKING ISSUE. THE USER CHANGED TO ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 06/10/2019: THE DEVICE WAS USED IN THE DUODENAL PAPILLA. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8749404 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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