Percuflex™ M001245500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729178613), received between Jan 17, 2024 and Sep 25, 2025 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2025Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT DEVICE SEPARATION OCCURRED. A PERCUFLEX? DEVICE WAS SELECTED FOR USE DURING A NEPHROSTOMY INSERTION AND/OR URETERIC STENT INSERTION PROCEDURE. DURING THE PROCEDURE, WHEN THE STENT WAS INSERTED OVER THE WIRE, IT WAS DIFFICULT TO ADVANCE. THE THREAD WAS PULLED IN AN ATTEMPT TO REPOSITION THE STENT TOWARDS THE INSERTION SITE; HOWEVER, THE STRING SNAPPED OFF THE STENT (WHICH REMAINED INTACT), AND THE STENT BECAME DEPLOYED IN A LESS-THAN-IDEAL POSITION. GIVEN THE STRICTURE, THE PHYSICIAN FELT THAT THE STENT SHOULD NOT MIGRATE. THE PATIENT WOULD RETURN FOR A SECOND PROCEDURE TO ASSESS THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23151490 ↗
• InjuryJan 17, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE STENT BROKE OFF AND WAS REMOVED WITH A SNARE. THE TARGET LESION WAS IN THE LEFT KIDNEY. A PERCUFLEX TEMPERATURE ABLATION CATHETER URETERAL STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT WAS PLACED IN A NORMAL FASHION. THE STABILIZER WAS BEING REMOVED WHEN THE PROXIMAL LOOP BROKE OFF A FEW CENTIMETERS FROM THE TAPERED END. THE TWO PIECES OF THE DEVICE WERE IN THE PATIENT AT THIS POINT. THE DOCTOR DECIDED TO ATTEMPT TO RETRIEVE THE PIECES THE FOLLOWING DAY, SO A NEPHROSTOMY TUBE WAS KEPT IN PLACE SO THAT THEY HAD ACCESS FOR THE RETRIEVAL PROCEDURE AND THE BROKEN DEVICE WAS RETRIEVED VIA SNARE THE NEXT DAY. HENCE, THE PHYSICIAN FELT THAT THE TUBE BROKE FROM THE PULLING OF THE STRING. THE PROCEDURE WAS COMPLETED WITH ANOTHER PERCUFLEX STENT. THE PATIENT HAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18527609 ↗