Percuflex™ Plus M0061752530Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 08714729056812), received between Nov 16, 2016 and Sep 22, 2026 — classified as 1 death, 13 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Break” (57 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. 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 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861534 ↗
• MalfunctionSep 10, 2026Break

  It was reported that a percuflex plus ureteral stent was used during transurethral laser lithotripsy and stone removal of the ureter/renal pelvis plus transurethral ureteral stent placement under general anesthesia with endotracheal intubation. During procedure, it was discovered that the stent was broken. The procedure was completed with another of the same stent. there were no patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713512 ↗
• MalfunctionSep 9, 2026Break; Detachment of Device or Device Component

  It was reported that a Percuflex Plus was to be used in a lithotripsy procedure. During unpacking, it was found that the stent was fractured. The procedure was completed with another of the same device and there were no patient complications reported. The patient condition following the procedure was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50683490 ↗
• MalfunctionAug 20, 2026Difficult to Advance; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50351078 ↗
• MalfunctionMay 7, 2026Material Deformation

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED IN A HOLMIUM LASER LITHOTRIPSY PROCEDURE IN THE KIDNEY. DURING INSERTION AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE TIP OF THE STENT WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25108648 ↗
• MalfunctionApr 21, 2026Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24934410 ↗
• MalfunctionMar 31, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT, DURING A LITHOTRIPSY PROCEDURE, A PERCUFLEX PLUS URETERAL STENT WAS INTENDED TO BE USED. DURING THE PREPARATION, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24739197 ↗
• MalfunctionFeb 25, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED IN A URETEROSCOPIC STENT PLACEMENT IN THE URETER. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE END OF THE STENT (LOOP) WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24439442 ↗
• MalfunctionFeb 13, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A STENT IMPLANTATION PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT SHAFT WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333901 ↗
• MalfunctionJan 21, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A CATHETERIZATION PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE SEAL OF THE PACKAGING WAS DAMAGED. THE PROCEDURE WAS COMPLETED OF ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127497 ↗
• InjuryJan 12, 2026Material Deformation; Material Integrity Problem; Migration

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS PLACED INTO THE PATIENT DURING A LITHOTRIPSY ON URETER WITH FLEX PROCEDURE IN THE KIDNEY. POST PROCEDURE, THE PATIENT FELT THAT THE STENT WAS OUT OF THE URETHRA 4 HOURS AFTER THE STENT WAS IMPLANTED. ANOTHER PROCEDURE WAS PERFORMED TO REMOVE THE STENT, AND IT WAS NOTICED THAT THE STENT WAS STRAIGHT AND WAS REFORMED. THE STENT WAS SUCCESSFULLY REMOVED AND WAS REPLACED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. A MEDIA AND A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT DID NOT COIL AND WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049783 ↗
• MalfunctionDec 24, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A URETEROLITHOTOMY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888797 ↗
• MalfunctionDec 24, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A FLEXIBLE URETEROSCOPIC LITHOTRIPSY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. PICTURE PROVIDED BY THE CUSTOMER SHOWED THAT THE STENT SHAFT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886876 ↗
• InjuryDec 18, 2025Break; Break

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED IN A PROCEDURE IN THE URETER. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT BROKE INSIDE THE PATIENT. THE BROKEN STENT WAS RETRIEVED FROM THE PATIENT, AND A NEW STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842035 ↗
• MalfunctionDec 12, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A TRANSURETHRAL URETEROSCOPIC LASER LITHOTRIPSY OF RENAL PELVIS PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION WITH AN ATTACHED PHOTO OF THE COMPLAINT DEVICE WAS RECEIVED ON JANUARY 07, 2026, CLARIFIED AND SHOWED THAT THE COIL WAS DETACHED DURING UNPACKING. THEREFORE, THIS IS CONSIDERED NON REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796536 ↗
• MalfunctionDec 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED IN A TRANSURETHRAL URETERAL HOLMIUM LASER LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PICTURE WAS PROVIDED BY THE COMPLAINANT SHOWING THAT THE COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23689531 ↗
• MalfunctionDec 1, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS PLACED IN A PATIENT DURING A BILATERAL URETERAL STENT PLACEMENT PROCEDURE. THREE MONTHS FOLLOWING THE PROCEDURE, THERE WAS RECURRENCE OF HYDRONEPHROSIS AND INFECTION, AND THE STENT WAS DIFFICULT TO REMOVE. NO MEDICAL INTERVENTION WAS NOTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection; Unspecified Kidney or Urinary Problem

  MAUDE report 23689421 ↗
• MalfunctionNov 14, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A RETROGRADE INTRARENAL SURGERY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE TIP AND ALONG THAT SHAFT OF THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556344 ↗
• MalfunctionOct 22, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT USED IN A CYSTOSCOPY, TRANSURETHRAL RESECTION OF BLADDER TUMOR AND RIGHT URETERAL STENT PLACEMENT PROCEDURE IN THE RIGHT URETER. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364178 ↗
• MalfunctionOct 6, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 23, 2025, STATING THAT, THE COIL/PIGTAIL WAS DETACHED AT THE END OF THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23224017 ↗
• MalfunctionOct 2, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A TRANSURETHRAL URETEROSCOPIC LASER LITHOTRIPSY OF LEFT RENAL PELVIS PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE TIP OF THE STENT WAS KINKED AND DAMAGED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 28, 2025, CLARIFIED THAT THE PROCEDURE WAS NOT CANCELLED AND WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23197313 ↗
• MalfunctionSep 26, 2025Break; Break

  IT WAS REPORTED THAT PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A RIGID URETEROSCOPIC LITHOTRIPSY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23158411 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A PROCEDURE FOR URETERAL STONE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22981409 ↗
• MalfunctionSep 3, 2025Break; Nonstandard Device; Break

  IT WAS REPORTED THAT DURING UNPACKING, IT WAS FOUND TO BE DAMAGED WHEN UNPACKED BEFORE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956833 ↗
• MalfunctionAug 20, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A PERCUFLEX PLUS WAS TO BE USED IN A FLEXIBLE URETEROSCOPE LITHOTOMY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE PACKAGING WAS DAMAGED. IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22857384 ↗