Flexi-Tip G14809Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002148093), received between Apr 27, 2016 and Mar 31, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Separation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, AN OPEN-END FLEXI-TIP URETERAL CATHETER DELAMINATED WHEN COMING INTO CONTACT WITH A CYSTOSCOPE. "DEBRIS" WAS REMOVED FROM THE PATIENT BY UNKNOWN MEANS. A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE, AND THERE WAS NO FURTHER IMPACT TO THE PATIENT. ADDITIONAL EVENT AND PATIENT OUTCOME INFORMATION HAVE BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13964289 ↗
• InjuryJul 6, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON THE RIGHT URETER, A PIECE OF THE OPEN-END FLEXI-TIP URETERAL CATHETER PROBE BECAME UNATTACHED WHILE THE CATHETER PROBE WAS BEING REMOVED AND REMAINED IN THE PATIENT. THE SEPARATED DEVICE FRAGMENT MIGRATED AND BECAME STUCK IN THE RIGHT URETER. THE PHYSICIAN SUCCESSFULLY RECOVERED ALL PROBE FRAGMENTS USING A FOREIGN BODY CLAMP. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 12120674 ↗
• InjuryFeb 17, 2021Material Separation

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

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 11338825 ↗
• InjuryApr 27, 2016Material Separation; Material Separation

  THE DEVICE WAS PLACED ON (B)(6) 2016. ON (B)(6) 2016, A NEW INTERVENTION WAS PERFORMED FOR REMOVAL OF A KIDNEY STONE UNDER RENO FIBROSCOPY. DURING, THE PROCEDURE THE DEVICE SEPARATED INTO 2 PIECES. ONE PORTION MIGRATED INTO THE KIDNEY AND THE OTHER INTO THE BLADDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. HOWEVER, IT WAS NOT PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 5611135 ↗