Flexi-Tip G15040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002150409), received between Dec 12, 2016 and Dec 12, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionDec 12, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED 06MAR2026. THE CATHETER DID GO THROUGH A SCOPE. THE SCOPE WAS CHECKED AND NO DAMAGED WAS OBSERVED. THE EVENT OCCURRED DURING A URETEROSCOPY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23787007 ↗
• MalfunctionJul 9, 2020Fracture; Fracture

  ADDITIONAL INFORMATION PROVIDED 22JUL2020: THE COMPLAINT DEVICE WAS BEING USED WITH A 5.3CM DIAMETER STORZ ANKLIN HYSTEROSCOPE, AND AN ANKLIN TOWER. THE CATHETER WAS PLACED THROUGH THE HYSTEROSCOPE. THERE WAS NO MANIPULATION BY THE SURGEON, AND NO DAMAGE/DEFECT ON THE SCOPE. THE REAR PART OF THE CATHETER WAS CUT OFF BECAUSE THERE WAS NOTHING DEFECTIVE ON THE PART, AND THE REMAINING CATHETER WAS SENT FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10250395 ↗
• MalfunctionJul 26, 2019Material Puncture/Hole; Material Puncture/Hole

  ADDITIONAL INFORMATION WAS RECEIVED ON 15AUG2019: THE FOLDED CATHETER WAS FOUND DURING THE PREPARATION PROCESS OF AN UNKNOWN PROCEDURE. DUE TO THE FACT THAT THIS WAS FOUND DURING THE PREPPING PROCESS THERE WAS NO PATIENT CONTACT. ANOTHER PRODUCT WAS OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8832961 ↗
• InjuryDec 12, 2016Material Separation; Material Separation

  IT WAS REPORTED WHILE DOING A CYSTOSCOPY FOR INSERTION OFF A STENT, THE URETERAL CATHETER WAS INSERTED THROUGH THE CYSTOSCOPE INTO THE URETER, THE PHYSICIAN PULLED BACK ON THE CYSTOSCOPE TO CHECK THE POSITION AND FOUND THE URETERAL CATHETER HAD SNAPPED INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO REMOVE THE SNAPPED OFF END. 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 Known Impact Or Consequence To Patient

  MAUDE report 6166339 ↗