Percuflex™ Plus M0061752520Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729056805), received between May 1, 2017 and Apr 9, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED IN A URETEROSCOPIC INTERVENTION PROCEDURE IN THE URETER. DURING PROCEDURE CLOSURE, IT WAS NOTICED THAT THE FRONT END OF THE STENT WAS FRACTURED BUT DID NOT FALL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24837969 ↗
• MalfunctionJan 9, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED IN A PROCEDURE IN THE LEFT URETER. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT BROKE UPON INSERTING INTO THE ANATOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023765 ↗
• MalfunctionNov 5, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PREPARATION, THE PERCUFLEX PLUS URETHRAL STENT MEDICAL DEVICE WAS TRANSFERRED TO THE SURGICAL TABLE. UPON OPENING THE STERILE PRIMARY PACKAGING, IT WAS FOUND THAT THE STENT COIL WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480503 ↗
• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A LITHOTRIPSY PROCEDURE IN THE KIDNEY. DURING PREPARATION, IT WAS FOUND THAT THE STENT WAS BROKEN. THE PROCEDURE WAS COMPETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22960050 ↗
• MalfunctionAug 26, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED IN AN IMPLANTATION OF URETER PROCEDURE. DURING UNPACKING, THE DEVICE WAS FOUND 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 22898361 ↗
• MalfunctionAug 12, 2025Break; Nonstandard Device; Detachment of Device or Device Component; Break; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING UNPACKING, WHEN THE PACKAGE WAS OPENED, ONE END OF THE URETERAL STENT WAS FOUND TO BE 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 22780258 ↗
• MalfunctionJun 20, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, IT WAS IDENTIFIED THAT THE 4.8 FR DOUBLE J CATHETER HAD VISIBLE STRUCTURAL DAMAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION AFTER THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303019 ↗
• MalfunctionJul 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE USING A PERCUFLEX PLUS STENT, IT WAS NOTICED DURING INSERTION THAT THE STENT BROKE. ANOTHER OF THE SAME STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684472 ↗
• MalfunctionFeb 12, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS OPENED FOR USE DURING A URETERAL CATHETERIZATION PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2024. DURING PREPARATION, WHEN THE DEVICE WAS UNPACKED, THE PIGTAIL WAS FOUND FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER PERCUFLEX PLUS URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE DISTAL END OF THE STENT SHAFT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686762 ↗
• MalfunctionNov 13, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, IT WAS NOTED THAT THE CATHETER WAS FOUND BROKEN WHEN OPENING THE SECONDARY PACKAGING OF THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18127519 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX URETERAL STENT WAS IMPLANTED DURING A LASER LITHOTRIPSY PROCEDURE IN THE LEFT URETER ON (B)(6) 2022, AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. ON (B)(6) 2022, THE STENT WAS SUCCESSFULLY IMPLANTED, AND A MEDICATION OF ACETAMINOPHEN TYLENOL, ALPHA BLOCKER, ZOFRAN AND ANTICHOLINERGIC WAS GIVEN FOR THE PATIENT'S LEFT FLANK PAIN. ON (B)(6) 2022, IT WAS NOTED THAT THE STENT WAS REMOVED SUCCESSFULLY, AND PAIN CONTROL WAS NOT REQUIRED. ON (B)(6) 2022, THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 15839825 ↗
• MalfunctionSep 26, 2022Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486089 ↗
• MalfunctionJul 22, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A PROCEDURE IN THE URETER PERFORMED ON (B)(6)2022. DURING THE PROCEDURE, WHEN THE PUSHER WAS PLACED, THE COIL WAS POSITIONED IN THE LEFT URETER AND IN THE RIGHT URETER IT WAS CROWDED AND NEITHER THE GUIDE NOR THE PUSHER ADVANCED, MUCH LESS THE FRACTIONATED CATHETER, THE URETER OF THE PATIENT WITH EVIDENCE OF BLEEDING WAS REMOVED WITH DIFFICULTY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15090098 ↗
• MalfunctionMar 5, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A FLEXIBLE URETEROSCOPY PROCEDURE, PERFORMED ON (B)(6), 2021. IT WAS REPORTED THAT WHEN THE PHYSICIAN UNPACKED THE PACKAGE, IT WAS NOTICED THAT THE STENT WAS "BURST". THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11419076 ↗
• MalfunctionJan 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE IN THE KIDNEY, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN WAS USING THE PUSHER ON THE STENT, WHILE INSIDE THE SCOPE WORKING CHANNEL, IT WAS NOTICED THAT THE STENT WAS KINKED. THE PHYSICIAN REMOVED THE STENT AND ANOTHER PERCUFLEX PLUS URETERAL STENT WAS OPENED, WHICH SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11141920 ↗
• MalfunctionNov 19, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS OPENED TO BE USED DURING A PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN UNPACKED THE PACKAGE, IT WAS NOTICED THAT THE STENT WAS FRACTURED. ANOTHER PERCUFLEX PLUS URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10867659 ↗
• MalfunctionSep 30, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS OPEN TO BE USED DURING AN INTRACORPOREAL STONE FRAGMENTATION PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT A PART OF THE CATHETER WAS DETACHED. ANOTHER PERCUFLEX PLUS URETERAL STENT WAS OPENED WAS OPENED, AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10606119 ↗
• MalfunctionJun 8, 2020Break; Break

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A URETERAL STONES PROCEDURE FOR FLUID RETENTION IN THE LEFT KIDNEY PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN THE PHYSICIAN UNPACKED THE STENT, IT WAS NOTICED THAT THE STENT WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PERCUFLEX PLUS URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10130606 ↗
• MalfunctionMay 14, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A URETERAL LITHOTOMY UNDER RIGID URETEROSCOPIC PROCEDURE IN THE UPPER URETER, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN UNPACKED THE PERCUFLEX PLUS URETERAL STENT IT WAS FOUND FRACTURED. ANOTHER PERCUFLEX PLUS URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ** ADDITIONAL INFORMATION RECEIVED ON MAY 14, 2020 ** THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10058400 ↗
• MalfunctionMay 1, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX¿ PLUS URETERAL STENT WAS USED IN THE URETER DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING INTRODUCTION, THE STENT WAS DETACHED INSIDE THE PATIENT. THE DETACHED PIECE WAS SUCCESSFULLY REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER PERCUFLEX¿ PLUS URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE ¿STABLE.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6535811 ↗