Flexima™ M001271790Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729323303), received between Oct 4, 2022 and Apr 2, 2024 — classified as 2 injuries, 2 malfunctions.

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

• MalfunctionApr 2, 2024Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06MAR2024. IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO ADVANCE. AN 8F FLEXIMA NEPHROSTOMY CATHETER SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, A HARD RESISTANCE WAS ENCOUNTERED UPON PUSHING THE CATHETER IN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED, AND THE PATIENT'S CONDITION WAS NORMAL. HOWEVER, INVESTIGATION OF THE RETURNED DEVICE REVEALED THAT THE SUTURE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021708 ↗
• InjuryJul 31, 2023Break; Break

  IT WAS REPORTED THAT THE STIFFENER GOT DETACHED AND PERFORATED THE KIDNEY HILUM. THE TARGET LESION WAS LOCATED IN THE KIDNEY AREA. A FLEXIMA CATHETER DRAINAGE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE HUB OF THE STIFFENER GOT DETACHED, CAUSING THE STIFFENER TO ADVANCE THE CATHETER AND PERFORATE THE KIDNEY HILUM. THE DEVICE WAS REMOVED WITH EASE. A NEW NEPHROSTOMY TUBE WAS PLACED, SINCE THE PERFORATED RENAL PELVIS WILL HEAL ON ITS OWN. THE PHYSICIAN REVIEWED THE CT AND THERE WAS NO BLOOD VESSEL MEDIAL TO THE SITE OF PERFORATION. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION WAS PERFORMED. ONLY HUB CANNULA AND AN ACCESSORY WERE RETURNED FOR ANALYSIS. IT IS EVIDENCING THE SEPARATION OF THE METAL CANNULA FROM THE HUB. THE POUCH WAS RETURNED, AND IT WAS OBSERVED THAT THE POUCH INFORMATION MATCHES WITH THE COMPLAINT INFORMATION. NO ISSUES WERE OBSERVED IN THE DEVICES.

  Patient problems: Perforation

  MAUDE report 17426226 ↗
• InjuryJul 28, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT PATIENT INJURY OCCURRED. AN 8.3 FLEXIMA DRAINAGE CATHETER WAS SELECTED FOR RIGHT NEPHROSTOMY PLACEMENT IN THE KIDNEY. DURING THE PROCEDURE, IT WAS NOTED THAT THE RENAL COLLECTING SYSTEM WAS RUPTURED DUE TO INABILITY TO FEED OFF CATHETER FROM METAL STIFFENER. THE PATIENT HAS FULLY RECOVERED.

  Patient problems: Internal Organ Perforation

  MAUDE report 17418984 ↗
• MalfunctionOct 4, 2022Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT THE CATHETER BROKE. A FLEXIMA NEPHROSTOMY DRAINAGE CATHETER HAD BEEN PLACED FOR DRAINAGE OF THE KIDNEY. IT WAS NOTED THERE WAS DIFFICULTY PULLING THE SUTURE AND THE CATHETER BROKE. A NEW FLEXIMA CATHETER WAS USED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538783 ↗