Flexi-Tip G17323Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002173231), received between Nov 14, 2016 and Mar 27, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2019Material Separation; Material Separation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8458558 ↗
• MalfunctionMar 27, 2019Material Separation; Material Separation

  THERE IS NO NEW EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8458329 ↗
• InjuryNov 14, 2016Break; Break

  IT WAS REPORTED DURING A URETEROSCOPY IN THE UPPER URINARY TRACT THE TIP OF THE DUAL LUMEN CATHETER BROKE OFF INTO THE KIDNEY AND HAD TO BE RETRIEVED USING GRASPERS. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6098775 ↗