C-Flex G14834Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002148345), received between Apr 10, 2018 and Sep 16, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

• InjurySep 16, 2026Break

  It was reported that the stent from a C-Flex Double Pigtail Ureteral Stent Set separated.During an endoscopy procedure on (b)(6) 2026 to remove the stent that had been placed on (b)(6) 2026, the surgeon found black fragments in the patient's bladder that appeared to originate from the stent. The surgeon proceeded to remove a nearly complete ring plus a few fragments. Examination of the stent found the appearance to be unremarkable except for the two missing black bands, one of which is normally present at each end of the stent. No complications occurred during the stone removal procedure; however, there was a risk of stone formation.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence. Additional information regarding the event and patient outcome has been requested but is currently unavailable.

  Patient problems: Foreign Body In Patient

  MAUDE report 50793120 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED, DURING A URETEROSCOPY, WHEN A STENT FROM A C-FLEX DOUBLE PIGTAIL URETERAL STENT SET WAS INSERTED, THE SURGEON NOTICED ONE OF THE PIGTAIL ENDS WAS CRACKED AND SOME SMALL FRAGMENTS OF THE OUTER COATING FLAKED OFF. THE STENT WAS IMMEDIATELY REMOVED AND REPLACED WITH ANOTHER ONE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523291 ↗
• MalfunctionJun 16, 2025Break; Break

  IT WAS REPORTED DURING A ROBOTIC PYELOPLASTY PROCEDURE, DURING URETERAL STENT PLACEMENT, THE STENT OF A C-FLEX DOUBLE PIGTAIL URETERAL STENT SET BROKE INTO PIECES WHEN THE STENT WAS BEING WETTED WITH SALINE. THE PROCEDURE WAS CONTINUED WITHOUT STENT PLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212657 ↗
• MalfunctionMay 15, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED 26MAY2023: THE PROCEDURE STARTED WITH A URETERAL STONE REMOVAL WHILE DOING A CYSTOSCOPY. DURING THE PROCEDURE, THE DOCTOR NOTICED THE STENT MIGRATED TO THE URETER. A URETEROSCOPY PROCEDURE WAS COMPLETED TO FIND THE REST OF THE STENT. THE STENT WAS REMOVED AND NO LONGER IN THE PATIENT. THE IMPLANT DATE OF THE STENT WAS ON (B)(6) 2022 AND THE EXPLANT DATE OF THE STENT WAS ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16934917 ↗
• MalfunctionJan 18, 2022Break; Break

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE A C-FLEX DOUBLE PIGTAIL URETERAL STENT SET WAS FOUND BROKEN UPON OPENING THE PACKAGING. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PORTION OF THE DEVICE WAS LEFT WITHIN THE PATIENT. THERE WAS NO NEED FOR ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATIONS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13283053 ↗
• MalfunctionJan 18, 2022Break; Break

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE A C-FLEX DOUBLE PIGTAIL URETERAL STENT SET BECAME "SHREDDED". IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PORTION OF THE DEVICE WAS LEFT WITHIN THE PATIENT. THERE WAS NO NEED FOR ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATIONS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282998 ↗
• MalfunctionJan 4, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, DURING A LAPAROSCOPIC PYELOPLASTY, THE COATING OF A WIRE GUIDE OF A C-FLEX DOUBLE PIGTAIL URETERAL STENT SET SEPARATED FROM THE WIRE. THE WIRE WAS ACTIVATED USING WATER AND HANDLED USING LATEX GLOVES. THE WIRE AND STENT WERE PLACED IN THE URETER WITHOUT COMPLICATION. AS THE WIRE GUIDE WAS REMOVED, THE COATING PEELED FROM THE DEVICE, AND THE STENT LOST ITS SHAPE. THE STENT WAS WITHDRAWN FROM THE PATIENT. A PHOTO OF THE STENT APPEARS TO SHOW THE DISTAL TIP DAMAGED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152901 ↗
• MalfunctionApr 10, 2018Material Separation; Stretched

  THE COMPLAINANT REPORTED THAT THE C-FLEX DOUBLE PIGTAIL URETERAL STENT "BOUND UP" ON THE WIRE DURING A CASE. IT WAS FURTHER NOTED THAT THE COILS ON THE WIRE WERE SLIGHTLY STRETCHED AND THE INNER WIRE SEPARATED FROM THE WELDED BALL. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE REPORTED PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7419066 ↗
• MalfunctionApr 10, 2018Flaked; Material Separation

  IT WAS REPORTED THAT WHEN THE C-FLEX DOUBLE PIGTAIL URETERAL STENT SET PACKAGE WAS OPENED, THE PHYSICIAN NOTICED THAT THE WIRE GUIDE COATING WAS FLAKING. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. ALSO, IT WAS NOTED THAT THE WIRE'S DISTAL WELD HAD SEPARATED, CAUSING ELONGATION OF THE COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7414255 ↗