PercuflexRecalls & reported problems across all models

We found 18 models of Percuflex by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 94 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2018 and Sep 30, 2026 — classified as 12 injuries, 82 malfunctions.

The most frequently reported specific device problem is “Break” (50 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Percuflex problems

Percuflex models

18 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Percuflex™ M0061453520

  STENT, URETERAL
  52 reports
• Percuflex™ M0061453620

  STENT, URETERAL
  13 reports
• Percuflex™ M0061453510

  STENT, URETERAL
  4 reports
• Percuflex™ M0061453610

  STENT, URETERAL
  3 reports
• Percuflex™ M0061453730

  STENT, URETERAL
  3 reports
• Percuflex™ M001245530

  STENT, URETERAL
  3 reports
• Percuflex™ M001235600

  STENT, URETERAL
  2 reports
• Percuflex™ M001245640

  STENT, URETERAL
  2 reports
• Percuflex™ M001245740

  STENT, URETERAL
  2 reports
• Percuflex™ M001245500

  STENT, URETERAL
  2 reports
• Percuflex™ M001235510

  STENT, URETERAL
  1 report
• Percuflex™ M001245630

  STENT, URETERAL
  1 report
• Percuflex™ M0061453530

  STENT, URETERAL
  1 report
• Percuflex™ M0061453720

  STENT, URETERAL
  1 report
• Percuflex™ M001245750

  STENT, URETERAL
  1 report
• Percuflex™ M001245520

  STENT, URETERAL
  1 report
• Percuflex™ M001245510

  STENT, URETERAL
  1 report
• Percuflex™ M006145352190

  STENT, URETERAL
  1 report

Recent Percuflex adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJun 18, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS TO BE USED IN A FLEXIBLE URETEROSCOPIC LITHOTRIPSY AND STONE EXTRACTION WITH POSTOPERATIVE STENT PLACEMENT. DURING UNPACKING IT WAS FOUND THAT THE PACKAGING WAS OPENED AND FOUND TO BE DAMAGED. DUE TO THE COMPROMISED INTEGRITY OF THE PACKAGING, CONTAMINATION OF THE DEVICE WAS SUSPECTED. THE DEVICE WAS THEREFORE DEEMED UNSUITABLE FOR USE AND WAS NOT UTILIZED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552257 ↗
• MalfunctionMay 12, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT PERCUFLEX URETERAL STENT WAS USED IN A LITHOTRIPSY FOR LEFT RENAL STONE PROCEDURE IN THE LEFT KIDNEY. DURING INSERTION AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS WRINKLED AND COULD NOT BE PLACED. 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 25154974 ↗
• 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 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 ↗
• 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 ↗

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