Percuflex™ Plus M0061752630Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 08714729041184), received between May 24, 2017 and Sep 18, 2026 — classified as 16 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 46 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Break; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation

  It was reported that a Percuflex Plus Ureteral stent was implanted into the right ureter of the patient during a double J (JJ) stent placement performed on, (b)(6) 2026. Post procedure, on the same date, the patient experienced abdominal pain. The following day, (b)(6) 2026, X-ray imaging revealed that the stent had broken inside the patient. On (b)(6) 2026, endoscopic surgery was performed to remove the broken stent, however, the coil could not be removed and was left unretrieved. The patient's condition was stable at the conclusion of this procedure, however, further hospital observation was required. On (b)(6) 2026, another endoscopic surgery was performed and successfully retrieved all broken fragments. There was no information if a new stent was replaced and there was no information if medication was given for pain, however, it was reported that the adverse event of pain was resolved. The patient's condition following the procedure was stable.

  Patient problems: Abdominal Pain; Foreign Body In Patient

  MAUDE report 50817285 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, A PERCUFLEX URETERAL STENT WAS TO BE USED. WHEN THE DEVICE WAS OPENED, IT WAS NOTICED THAT THE STENT WAS BROKEN. ANOTHER STENT WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955488 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A LITHOTRIPSY PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS BROKEN. 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 24247322 ↗
• MalfunctionNov 24, 2025Nonstandard Device; Detachment of Device or Device Component; Material Integrity Problem; Nonstandard Device; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A RIGHT-SIDED URETEROSCOPY-URETERAL STENT REPLACEMENT PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE STENT WAS 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 DECEMBER 01, 2025, WITH AN ATTACHED PHOTO OF THE COMPLAINT DEVICE SHOWING THAT THE COIL WAS DETACHED, AND STATING THAT, THE PROCEDURE HAS BEEN COMPLETED WITH ANOTHER OF THE SAME DEVICE ON THE RESCHEDULED DATE ON (B)(6), 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23639447 ↗
• MalfunctionNov 21, 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 URETERAL CALCULI PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT ONE END OF 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 COIL AND A PART OF THE STENT SHAFT WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618854 ↗
• MalfunctionNov 11, 2025Break; Break

  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 STENT 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 23523213 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS IMPLANTED IN A PATIENT DURING A KIDNEY STONE REMOVAL PROCEDURE. FOLLOWING THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN. THE STENT WAS REMOVED ON (B)(6) 2025. THERE WERE NO OTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Pain

  MAUDE report 23293884 ↗
• MalfunctionAug 26, 2025Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED IN A URETERECTOMY PROCEDURE. DURING THE PROCEDURE, WHEN THE DEVICE WAS PLACED, IT WAS NOTICED THAT THE STENT WAS TWISTED, DAMAGED AND IT WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893916 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE BROKE OR FRACTURED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639036 ↗
• InjuryJul 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE URETEROSCOPY PROCEDURE, THE END OF THE OF STENT DID NOT COIL IN THE KIDNEY AND FELL OUT OF THE KIDNEY AS A RESULT. PROCEDURE WAS COMPLETED USING ANOTHER PERCUFLEX PLUS URETERAL STENT WITH NO ISSUES. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22619033 ↗
• MalfunctionJun 4, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING UNPACKING, IT WAS FOUND THAT THE DEVICE 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 22146812 ↗
• MalfunctionJan 24, 2025Break; Break

  IT WAS REPORTED THAT DURING THE FLEXIBLE URETEROSCOPIC LITHOTRIPSY PROCEDURE, THE STENT 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 21235664 ↗
• InjuryJan 10, 2025Calcified; Difficult to Remove; Calcified; Difficult to Remove

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS IMPLANTED DURING A STENT REPLACEMENT PROCEDURE. ON (B)(6) 2024, A LITHOTRIPSY FOR STENT REMOVAL WAS PERFORMED, AND, DURING THIS PROCEDURE, IT WAS FOUND THAT STONES WERE ATTACHED ON THE WALLS OF BOTH TUBES AND COULD NOT BE REMOVED. A HOLMIUM LASER LITHOTRIPSY UNDER GENERAL ANESTHESIA WAS PERFORMED TO REMOVE THE IMPLANTED STENT WHICH INCREASED THE PATIENT'S EXPENSES AND TREATMENT. THERE WAS NO INFORMATION IF A NEW STENT WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21123778 ↗
• InjuryOct 2, 2024Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT HAD HIS URETERAL STENT REMOVED ONE MONTH AFTER SURGERY FOR BILATERAL KIDNEY STONES. DURING SURGERY, IT WAS FOUND THAT THE URETERAL STENT WAS FULL OF STONES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351420 ↗
• MalfunctionMay 7, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PREPARATION, WHEN THE DEVICE WAS UNPACKED, THE STENT WAS FOUND FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME STENT AND 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19261517 ↗
• MalfunctionApr 19, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE DEVICE WAS UNPACKED, THE STENT 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19149316 ↗
• InjuryDec 14, 2023Calcified; Difficult to Remove; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Calcified; Difficult to Remove; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS SUCCESSFULLY IMPLANTED DURING A PROCEDURE IN THE UROGENITAL TRACT. THE EVENT DATE WAS UNKNOWN. DURING A PLANNED STENT REMOVAL, AFTER THREE MONTHS OF BEING IMPLANTED, IT WAS NOTED THAT THE STENT HAD HIGH ENCRUSTATION RATE AND LIGHT STONES. IT WAS MENTIONED THAT THEY REQUIRE LASER LITHOTRIPSY PROCEDURE, AND IT TOOK THEM FOUR HOURS TO REMOVE THE STENT USING A STANDARD STAINLESS-STEEL GRIPPER UNDER GENERAL ANESTHESIA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THE PATIENT EXPERIENCED INFECTION AND WAS GIVEN A MEDICATION OF ANTIBIOTIC DRUGS.

  Patient problems: Unspecified Infection

  MAUDE report 18324231 ↗
• InjuryDec 12, 2023Calcified; Difficult to Remove; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Calcified; Difficult to Remove; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS SUCCESSFULLY IMPLANTED DURING A PROCEDURE. THE EVENT DATE WAS UNKNOWN. DURING A PLANNED STENT REMOVAL, AFTER FIVE MONTHS OF BEING IMPLANTED, IT WAS NOTED THAT THE STENT SHOWS A MASSIVE ENCRUSTATION. THEY USED A HOLMIUM LASER TO REMOVE AT LEAST ENOUGH ENCRUSTATION FROM THE BLADDER LOOP AND IT TOOK THEM FOUR HOURS TO REMOVE THE STENT USING A STANDARD STAINLESS-STEEL GRIPPER UNDER GENERAL ANESTHESIA. THE PATIENT EXPERIENCED INFECTION AND WAS GIVEN A MEDICATION OF ANTIBIOTIC DRUGS.

  Patient problems: Unspecified Infection

  MAUDE report 18315354 ↗
• InjuryDec 12, 2023Calcified; Difficult to Remove; Use of Device Problem; Calcified; Difficult to Remove; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS SUCCESSFULLY IMPLANTED DURING A PROCEDURE. THE EVENT DATE WAS UNKNOWN. AFTER FOUR MONTHS OF BEING IMPLANTED, IT WAS NOTED THAT THE STENT WAS ENCRUSTED. IT WAS MENTIONED THAT IT TOOK A LONG DURATION OF INTERVENTION. 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 18315353 ↗
• InjuryDec 12, 2023Calcified; Difficult to Remove; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Calcified; Difficult to Remove; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS SUCCESSFULLY IMPLANTED DURING A PROCEDURE IN THE UROGENITAL TRACT. THE EVENT DATE WAS UNKNOWN. DURING A PLANNED STENT REMOVAL, AFTER THREE TO FOUR MONTHS OF BEING IMPLANTED, IT WAS NOTED THAT THE STENT HAD A HIGH ENCRUSTATION RATE AND DISCOLORATION. IT WAS MENTIONED THAT IT TOOK THEM FOUR HOURS TO REMOVE THE STENT USING A STANDARD STAINLESS-STEEL GRIPPER UNDER GENERAL ANESTHESIA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THE PATIENT EXPERIENCED INFECTION AND WAS GIVEN A MEDICATION OF ANTIBIOTIC DRUGS.

  Patient problems: Unspecified Infection

  MAUDE report 18314964 ↗
• InjuryDec 12, 2023Calcified; Difficult to Remove; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Calcified; Difficult to Remove; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS SUCCESSFULLY IMPLANTED DURING A PROCEDURE. THE EVENT DATE WAS UNKNOWN. AFTER THREE MONTHS OF BEING IMPLANTED, DURING A PLANNED STONE REMOVAL, IT WAS NOTED THAT THE STENT WAS FOUND ENCRUSTED. IT WAS MENTIONED THAT A LASER WAS USED TO REMOVE THE ENCRUSTATION, AND IT TOOK THEM FOUR HOURS TO REMOVE THE STENT USING A STANDARD STEEL GRIPPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THE STENT WAS CALCIFIED. THE PATIENT DEVELOPED SEPSIS AND IS NOW IN THE PALLIATIVE DEPARTMENT. NO OTHER MEDICATIONS WERE GIVEN.

  Patient problems: Sepsis

  MAUDE report 18312707 ↗
• MalfunctionNov 14, 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, WHEN THE DEVICE WAS UNPACKED, IT WAS FOUND THAT THE DEVICE WAS BROKEN. 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 18132461 ↗
• MalfunctionOct 16, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS OPENED TO BE USED DURING A TRANSURETEROSCOPIC LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2023. DURING PREPARATION, IT WAS FOUND THAT THE MIDDLE OF URETERAL STENT HAD 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 STENT SHAFT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17941381 ↗
• MalfunctionOct 2, 2023Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A KIDNEY TRANSPLANT PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE TAIL END OF THE DEVICE WAS 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 STENT WAS KINKED AND TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17857960 ↗
• MalfunctionApr 7, 2023Break; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Break; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS INTENDED TO BE USED IN A FLEXIBLE URETEROSCOPE LITHOTRIPSY PROCEDURE IN THE LEFT RENAL FOR PELVIC STONE MANAGEMENT PERFORMED ON (B)(6) 2023. DURING PREPARATION, IT WAS FOUND THAT THE STENT WAS FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER PERCUFLEX PLUS URETERAL STENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE STENT HAD A TEAR AND THE SHAFT WAS BROKEN. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16703255 ↗