Percuflex™ M001235600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729031857), received between Mar 14, 2023 and Apr 6, 2023 — classified as 1 injury, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryApr 6, 2023Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED VIA ATTACHED MEDWATCH (B)(4) THAT STENT WAS DIFFICULT TO POSITION AND SUTURE DETACHMENT OCCURRED WHICH REQUIRED ADDITIONAL INTERVENTION. A PERCUFLEX URETERAL STENTS WAS USED IN THE URETER. DURING THE PROCEDURE, THE NEPHROURETERAL CATHETER WAS SUCCESSFULLY REMOVED OVER A GUIDEWIRE AND THEN PLACED AN 11 FRENCH PEEL-AWAY SHEATH. A 10 FRENCH BY 26-CM DOUBLE-J STENT WAS THEN ADVANCED OVER THE GUIDEWIRE. AFTER DEPLOYMENT OF THE STENT, IT PROMPTLY MIGRATED DISTALLY WITH THE DEFORMED PROXIMAL RETENTION LOOP "KINKING" IN THE URETER APPROXIMATELY 5-7 CM FROM THE RENAL PELVIS. THE EXTERNAL RETENTION "SUTURE" WAS FOUND TO BE UNASSOCIATED/DETACHED FROM THE PROXIMAL ASPECT OF THE DOUBLE J STENT UPON APPLYING TENSION TO IT. EXTENSIVE ATTEMPTS TO REPOSITION THE STENT USING VASCULAR SNARES AND MULTIPLE CATHETER AND GUIDEWIRE COMBINATIONS WERE ATTEMPTED BUT WERE UNSUCCESSFUL. THE STENT COULD NOT BE APPROPRIATELY ENGAGED AT ITS PROXIMAL ASPECT. MULTIPLE ATTEMPTS WERE MADE AT PASSAGE OF A GUIDEWIRE INTO THE STENT, WITHOUT SUCCESS. THEREFORE, A GUIDEWIRE WAS ADVANCED INTO THE URINARY BLADDER AND A VASCULAR SNARE WAS USED TO ENGAGE THE DISTAL ASPECT OF THE DOUBLE-J STENT WITHIN THE URINA

  Patient problems: Foreign Body In Patient

  MAUDE report 16694189 ↗
• MalfunctionMar 14, 2023Positioning Failure; Entrapment of Device; Detachment of Device or Device Component; Material Twisted/Bent; Migration; Material Split, Cut or Torn

  THE INTERVENTIONAL RADIOLOGIST SCHEDULED THE PATIENT FOR A PROCEDURE DURING WHICH HE INTENDED TO REMOVE THE PATIENT'S LEFT NEPHROURETERAL CATHETER AND REPLACE IT WITH A DOUBLE-J STENT. THE PHYSICIAN HAD SUCCESSFULLY REMOVED THE NEPHROURETERAL CATHETER OVER A GUIDEWIRE AND THEN PLACED AN 11 FRENCH PEEL-AWAY SHEATH. A 10 FRENCH BY 26-CM DOUBLE-J STENT WAS THEN ADVANCED OVER THE GUIDEWIRE. AFTER DEPLOYMENT OF THE STENT, IT PROMPTLY MIGRATED DISTALLY WITH THE DEFORMED PROXIMAL RETENTION LOOP "KINKING" IN THE URETER APPROXIMATELY 5-7 CM FROM THE RENAL PELVIS. THE EXTERNAL RETENTION "SUTURE" WAS FOUND TO BE UNASSOCIATED/DETACHED FROM THE PROXIMAL ASPECT OF THE DOUBLE J STENT UPON APPLYING TENSION TO IT. EXTENSIVE ATTEMPTS TO REPOSITION THE STENT USING VASCULAR SNARES AND MULTIPLE CATHETER AND GUIDEWIRE COMBINATIONS WERE ATTEMPTED BUT WERE UNSUCCESSFUL. THE STENT COULD NOT BE APPROPRIATELY ENGAGED AT ITS PROXIMAL ASPECT. MULTIPLE ATTEMPTS WERE MADE AT PASSAGE OF A GUIDEWIRE INTO THE STENT, WITHOUT SUCCESS. THEREFORE, A GUIDEWIRE WAS ADVANCED INTO THE URINARY BLADDER AND A VASCULAR SNARE WAS USED TO ENGAGE THE DISTAL ASPECT OF THE DOUBLE-J STENT WITHIN THE URINARY BLADDER. A SECOND 5 FRENC

  Patient problems: Foreign Body In Patient

  MAUDE report 16536613 ↗