C-Flex G14637Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002146372), received between Sep 8, 2016 and Mar 24, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

• InjuryMar 24, 2026Flaked

  THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H11.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674729 ↗
• InjuryMar 24, 2026Flaked

  THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H11.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674654 ↗
• InjuryJan 21, 2026Break

  AS REPORTED, DURING A CYSTOSCOPY PROCEDURE, THE TIP OF THE 4.0 FR/70 CM STENT INCLUDED IN THE 'C-FLEX DOUBLE PIGTAIL URETERAL STENT SET' BROKE INSIDE OF PATIENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 24131818 ↗
• InjurySep 27, 2021Material Separation; Material Separation

  ADDITIONAL AND CORRECTED INFORMATION WAS PROVIDED ON 20OCT2021: THE STENT WAS PLACED ON (B)(6) 2021, AND IT WAS REMOVED ON (B)(6) 2021 WHEN THE NOTED MALFUNCTION OCCURRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12533805 ↗
• MalfunctionOct 2, 2019Material Separation; Device Damaged by Another Device; Material Separation; Device Damaged by Another Device

  NO ADDITIONAL PATIENT OR EVENT INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 02OCT2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9145623 ↗
• MalfunctionMay 30, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A RED STRING PARTICLE TYPE FIBER INSIDE THE C-FLEX DOUBLE PIGTAIL URETERAL STENT SET PACKAGING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7552789 ↗
• InjurySep 8, 2016Break; Break

  INFORMATION WAS PROVIDED THAT UPON RETRIEVAL OF THE URETERAL STENT OUT OF THE PATIENT, THE STENT BROKE OFF INTO 2 PIECES. THE SURGEON HAD TO RESCOPE THE PATIENT TO SEE IF HE COULD ENDOSCOPICALLY RETRIEVE THE REST OF THE STENT. THE SURGEON WAS ABLE TO GRASP THE REST OF THE STENT AND PULL IT OUT THROUGH THE URETHRA. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5935610 ↗