Percuflex™ M0061453520Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 08714729040279), received between Jan 4, 2021 and Sep 30, 2026 — classified as 4 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Difficult to Advance; Material Deformation

  It was reported that during the procedure, a ureteral stent was placed and has a significant resistance and could not be advanced, it was found that both end of the stent was deformed and prolonged the placement process as one stent had to be replaced during the procedure. This resulted in an extended surgical duration and may have caused abrasions to the ureteral mucosa. The procedure was completed with another of the same device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942138 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a Percuflex Ureteral Stent was used during left ureteroscopic holmium laser lithotripsy and stone removal under general anesthesia and antimicrobial therapy. During the procedure, a ureteral stent was placed postoperatively to dilate the ureter and provide internal drainage to protect renal function. The patient was discharged following the procedure. However, due to pain on the affected side of the lower back and abdomen, accompanied by fever, the patient was readmitted on (b)(6) 2026, for antimicrobial therapy, and the ureteral stent was removed at a later date. The procedure was completed. Additional medical surgical intervention required.

  Patient problems: Fever; Pain

  MAUDE report 50604424 ↗
• MalfunctionAug 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50416041 ↗
• MalfunctionAug 24, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410391 ↗
• MalfunctionMar 3, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS USED IN A LITHOTRIPSY FOR RIGHT RENAL STONE PROCEDURE IN THE RIGHT KIDNEY. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS WRINKLED. 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 24492884 ↗
• MalfunctionMar 3, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS USED IN A LITHOTRIPSY FOR LEFT RENAL CALCULI PROCEDURE IN THE LEFT KIDNEY. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS WRINKLED. 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 24492771 ↗
• MalfunctionFeb 5, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT, DURING RIGID URETEROSCOPIC LITHOTRIPSY PROCEDURE, A PERCUFLEX URETERAL STENT WAS TO BE USED, DURING PREPARATION, IT WAS FOUND THAT THE STENT SHAFT WAS BROKEN. 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 24274426 ↗
• MalfunctionDec 4, 2025Nonstandard Device; Material Deformation; Nonstandard Device; Material Deformation

  IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS USED IN A LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT WAS KINKED AND TWISTED. 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 23722455 ↗
• MalfunctionNov 26, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS USED DURING A LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS FOLDED AND TWISTED AND COULD NOT BE USED. 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 23659384 ↗
• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS USED IN A URETERAL STENT DILATION PROCEDURE IN THE URETER. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT WAS BROKEN WHICH CAUSED A DELAY. 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 23375976 ↗
• MalfunctionOct 9, 2025Nonstandard Device; Material Deformation; Nonstandard Device; Material Deformation

  IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS USED IN LITHOTRIPSY FOR LEFT RENAL CALCULI PROCEDURE. DURING INSERTION, AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS FOLDED AND COULD NOT BE PLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DIFFERENT MODEL OF STENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23257241 ↗
• MalfunctionSep 24, 2025Break; Break

  IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS TO BE USED IN A URETERAL STENTING 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23130196 ↗
• MalfunctionSep 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS USED IN A PROCEDURE. DURING INSERTION AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT HAS AN ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. PICTURE PROVIDED BY THE CUSTOMER SHOWED THAT THE STENT COIL WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23034524 ↗
• MalfunctionAug 25, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS USED IN A PROCEDURE. DURING INSERTION AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE TIP OF THE STENT WAS WRINKLED. 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 22890311 ↗
• MalfunctionJul 31, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS TO BE USED IN A LITHOTRIPSY FOR RIGHT RENAL STONE PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE INNER PACKAGING WAS NOT SEALED AND COULD NOT MEET THE STERILE CONDITIONS. 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 22681356 ↗
• MalfunctionMay 30, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PREPARATION, WHEN THE PHYSICIAN OPENED THE PACKAGE AND IT WAS FOUND IT WAS FRACTURED. 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 22115120 ↗
• MalfunctionMay 28, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS FOUND THAT THE STENT WAS DAMAGED AND IT COULD NOT BE USED NORMALLY. AFTER THE PHYSICIAN'S ADVICE, A NEW URETERAL STENT WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22098957 ↗
• MalfunctionMay 7, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE URETERAL STENT WAS PREPARED TO PLACE, THE NURSE UNPACKED IT FOR THE PHYSICIAN. WHEN THE PHYSICIAN INSERTED THE URETERAL STENT INTO THE ZEBRA GUIDEWIRE, IT WAS FOUND DAMAGED AT THE TAIL END OF THE URETERAL STENT AND IMMEDIATELY INFORMED THE NURSE TO REPLACE IT. AFTER THE URETERAL STENT WAS REPLACED, THE PROCEDURE PROCEEDED SMOOTHLY AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981656 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT DURING TRANSURETHRAL RIGHT URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY AND URETERAL STENT IMPLANTATION, THE URETERAL STENT WAS FRACTURED WHEN IT WAS OPENED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761391 ↗
• MalfunctionMar 21, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PREPARATION, THE DEVICE WAS DAMAGED WHEN THE PACKAGE WAS OPENED. 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 21665747 ↗
• MalfunctionJan 24, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS USED DURING A PARTIAL CYSTECTOMY AND BILATERAL URETERAL STENTING PROCEDURE, AND, DURING THE PROCEDURE, THE CATHETER WALL WAS TWISTED AND WRINKLED. THE DEVICE WAS WITHDRAWN FROM THE PATIENT AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21235657 ↗
• MalfunctionJan 23, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS USED DURING A PARTIAL CYSTECTOMY AND BILATERAL URETERAL STENTING PROCEDURE AND DURING THE PROCEDURE, INSIDE THE PATIENT, THE STENT TWISTED AND WRINKLED. THE STENT WAS SUCCESSFULLY WITHDRAWN FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21225943 ↗
• MalfunctionJan 15, 2025Break; Difficult to Advance; Material Deformation; Material Split, Cut or Torn; Break; Difficult to Advance; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING INSERTION, RESISTANCE WAS FELT AT THE FRONT END OF THE STENT, AND FOLDS WERE OBSERVED AT THE BACK END OF THE STENT. THE PIGTAIL AT THE BLADDER END OF THE URETERAL STENT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME STENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21164032 ↗
• MalfunctionJan 14, 2025Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING INSERTION, LARGE RESISTANCE WAS ENCOUNTERED AT THE ANTERIOR END AND THERE WERE FOLDS FOUND AT THE POSTERIOR END OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154557 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT DURING PREPARATION, WHEN THE PACKAGING WAS OPENED, THE DEVICE WAS FOUND DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106374 ↗