Cook G14337Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002143371), received between Nov 27, 2018 and Mar 27, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2025Material Rupture; Material Rupture

  CORRECTION OF INITIAL AWARE DATE: 12MAR2025 NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707247 ↗
• MalfunctionJul 2, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THE UPJ OCCLUSION BALLOON CATHETER'S PACKAGE WAS FOUND UNSEALED PRIOR TO AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661107 ↗
• MalfunctionAug 23, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607305 ↗
• MalfunctionFeb 28, 2022Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED, THE PRIMARY PACKAGING OF THREE UPJ OCCLUSION BALLOON CATHETERS WERE FOUND TO BE "DETACHED FROM THE SEAL," BREAKING THE STERILE BARRIER. NO DAMAGE WAS OBSERVED TO THE OUTER PACKAGING. NO PATIENT WAS AFFECTED BY THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620202 ↗
• MalfunctionDec 6, 2021Unsealed Device Packaging; Unsealed Device Packaging

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12935216 ↗
• MalfunctionApr 6, 2021Obstruction of Flow; Obstruction of Flow

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618395 ↗
• MalfunctionJan 15, 2021Contamination /Decontamination Problem

  AS REPORTED, DURING A PERCUTANEOUS NEPHROLITHOTRIPSY, AN UNKNOWN WHITE SUBSTANCE WAS FOUND IN A UPJ OCCLUSION BALLOON CATHETER. AFTER INSERTING THE BALLOON CATHETER INTO THE PATIENT, THE PHYSICIAN INFLATED THE BALLOON AND INSERTED A SYRINGE INTO THE INJECTION PORT OF THE INFLATION/INJECTION ADAPTER FOR PYELOGRAPHY. HOWEVER, THE PHYSICIAN COULD NOT INJECT UROGRAFIN CONTRAST MEDIUM, AS IT WOULD NOT FLOW THROUGH THE PORT OF THE ADAPTER. ONCE THE DEVICE WAS REMOVED FROM THE PATIENT, THE PHYSICIAN REMOVED THE SCREW OF THE INJECTION PORT OF THE ADAPTER AND CONFIRMED A WHITE BURR-LIKE SUBSTANCE WAS STUCK/CLOGGED IN THE DEVICE. ANOTHER PRODUCT OF THE SAME REFERENCE NUMBER 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 11177822 ↗
• MalfunctionJan 7, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ADDITIONAL INFORMATION WAS RECEIVED 12JAN2021: WHILE ATTEMPTING TO ADJUST THE ADAPTOR MANY TIMES AND TIGHTENING IT STRONGLY, A PIECE OF THE ADAPTER BROKE OFF. WHILE REPLACING THE ADAPTOR, THE USER DISCOVERED THE FOREIGN SUBSTANCE IN THE PROXIMAL END OF THE BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11132766 ↗
• MalfunctionNov 27, 2018Fluid/Blood Leak; Inflation Problem; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT HYDRONEPHROSIS WAS INTENTIONALLY INDUCED WITH THE BALLOON TO MAKE PERCUTANEOUS RENAL PUNCTURE EASIER FOR PERCUTANEOUS NEPHROLITHOTRIPSY (PNL) PROCEDURE. THE UPJ OCCLUSION BALLOON CATHETER WAS ADVANCED OVER A WIRE GUIDE AND WHEN THE BALLOON REACHED THE URETEROPELVIC JUNCTION (UPJ), THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON AFTER CONNECTING A SYRINGE CONTAINED IN THE DEVICE SET TO THE DEVICE CONNECTOR. HOWEVER, THE BALLOON DID NOT INFLATE AND FLUID LEAKED FROM THE OPPOSITE END. IT WAS FURTHER NOTED THAT A DRIED WHITE SUBSTANCE WAS FOUND AROUND THE OBTURATOR AND THE BALLOON CATHETER. IN ADDITION, THE OBTURATOR/WIRE GUIDE WAS NOTED TO BE BROKEN AND STRETCHED OUT. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE. A NEW PRODUCT WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8108596 ↗