Percuflex™ Plus M0061752620Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729056829), received between Mar 23, 2017 and Aug 26, 2025 — classified as 10 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS TO BE USED IN A PROCEDURE. DURING UNPACKING, IT WAS FOUND THAT THE PRODUCT WAS DAMAGED. IT WAS REPORTED THAT THE DEVICE 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 22899329 ↗
• MalfunctionJul 18, 2025Break; Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Break; Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PERCUFLEX PLUS STENT WAS USED DURING A STENTING PROCEDURE. DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS FAULTY, IT WAS FRACTURED AND TORN. 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 22543511 ↗
• InjuryMar 13, 2025Migration; Migration

  IT WAS REPORTED THAT A PERCUFLEX PLUS STENT WAS IMPLANTED INTO THE PATIENT. A PLANNED STENT REMOVAL PROCEDURE WAS THEN PERFORMED TO EXPLANT THE STENT. DURING THIS PROCEDURE, IT WAS FOUND THAT THE STENT MIGRATED INTO THE URETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21600913 ↗
• MalfunctionMar 13, 2025Migration; Migration

  IT WAS REPORTED THAT A PERCUFLEX PLUS STENT WAS IMPLANTED INTO THE PATIENT. A PLANNED STENT REMOVAL PROCEDURE WAS THEN PERFORMED TO EXPLANT THE STENT. DURING THIS PROCEDURE, IT WAS FOUND THAT THE STENT MIGRATED INTO THE URETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599244 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, AN ISSUE WITH THE STENT BEING DAMAGED OUT OF THE BOX. 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 21370828 ↗
• InjuryDec 2, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS IMPLANTED ON (B)(6) 2024 AND WAS REMOVED ON (B)(6) 2024 DUE TO URETERAL OBSTRUCTION. ANOTHER PERCUFLEX PLUS URETERAL STENT WAS IMPLANTED ON (B)(6) 2024 AND WAS REMOVED ON (B)(6) 2024 DUE TO POSTOPERATIVE INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20824648 ↗
• InjuryNov 27, 2024Adverse 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 ON (B)(6) 2024 AND WAS REMOVED (B)(6) 2024 DUE TO A POSTOPERATIVE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20802742 ↗
• InjuryDec 13, 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 STONE REMOVAL, AFTER THREE MONTHS OF BEING IMPLANTED, IT WAS NOTED THAT THE STENT WAS FOUND ENCRUSTED AND NO LONGER VISIBLE. IT WAS MENTIONED THAT THE STENT COULD NOT BE GRASPED, SO, 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. 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 SUFFERED FROM SEPSIS AND IS NOW IN THE PALLIATIVE DEPARTMENT.

  Patient problems: Sepsis

  MAUDE report 18322966 ↗
• 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 TWO MONTHS OF BEING IMPLANTED, IT WAS NOTED THAT THE STENT WOULD NO LONGER COME OUT AND WAS COMPLETELY ENCRUSTED. 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 18315323 ↗
• MalfunctionNov 15, 2023Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A PERCUFLEX PLUS URETERAL STENT WAS BEING EXCHANGE FOR ANOTHER STENT DURING A PROCEDURE FOR UROLOGY STONE TREATMENT. THE EVENT DATE WAS UNKNOWN. IT WAS NOTED THAT THE STENT WAS PLACED SEVERAL MONTHS AGO. THE PROCEDURE WAS SUCCESSFUL. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THE STENT WAS CALCIFIED. 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 18144768 ↗
• MalfunctionDec 23, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE URETER. THE EVENT DATE WAS NOT REPORTED. DURING PREPARATION, IT WAS NOTED THAT WHEN TRYING TO REMOVE THE SUTURE FROM THE STENT, IT BECAME BROKEN. 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 16045606 ↗
• InjuryMay 20, 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 PREVIOUSLY IMPLANTED PERCUFLEX PLUS URETERAL STENT WAS REMOVED FROM THE RIGHT URETER, PERFORMED ON (B)(6) 2022 AS PART OF THE (B)(6) CLINICAL STUDY. ON (B)(6) 2022, THE PERCUFLEX PLUS URETERAL STENT WAS SUCCESSFULLY PLACED FOR STONE MANAGEMENT IN THE RIGHT URETER, AND THE PATIENT WAS PRESCRIBED THE DISCHARGE MEDICATIONS, ACETAMINOPHEN (TYLENOL) AND NON STEROIDAL ANTI INFLAMMATORY DRUGS (NSAID)S. NO ISSUES WERE NOTED WITH THE DEVICE. ON (B)(6) 2022, THE PATIENT HAD EXPERIENCED A RIGHT FLANK PAIN. THE PATIENT WAS GIVEN IBUPROFEN, AND FLOMAX TO TREAT THE PAIN. DURING THE PLANNED STENT REMOVAL PERFORMED ON (B)(6) 2022, THE PERCUFLEX PLUS URETERAL STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT ANY DIFFICULTY. THERE WERE NO NEW DEVICE IMPLANTED. ON (B)(6) 2022 THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: Pain

  MAUDE report 14457426 ↗
• InjuryMay 20, 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 PREVIOUSLY IMPLANTED PERCUFLEX PLUS URETERAL STENT WAS REMOVED FROM THE LEFT URETER, PERFORMED ON (B)(6) 2022 AS PART OF THE U0652 DOUBLE-J REGISTRY CLINICAL STUDY. ON (B)(6) 2022, THE PERCUFLEX PLUS URETERAL STENT WAS SUCCESSFULLY PLACED FOR STONE MANAGEMENT IN THE LEFT URETER, AND THE PATIENT WAS PRESCRIBED THE DISCHARGE MEDICATIONS, ACETAMINOPHEN (TYLENOL) AND NON STEROIDAL ANTI INFLAMMATORY DRUGS (NSAID)S. NO ISSUES WERE NOTED WITH THE DEVICE. ON (B)(6) 2022, THE PATIENT HAD EXPERIENCED A LEFT FLANK PAIN. THE PATIENT WAS GIVEN TORADOL, MORPHINR, IV FLUIDS, NORCO, KEFLEX, CIPRO TO TREAT THE PAIN. DURING THE PLANNED STENT REMOVAL PERFORMED ON (B)(6) 2022, THE PERCUFLEX PLUS URETERAL STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT ANY DIFFICULTY. THERE WAS NO NEW DEVICE IMPLANTED. ON (B)(6) 2022 THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: Pain

  MAUDE report 14455557 ↗
• InjuryJun 28, 2019Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC COPORATION THAT A PREVIOUSLY IMPLANTED PERCUFLEX PLUS STENT WAS ATTEMPTED TO BE REMOVED FROM A PATIENT DURING A PROCEDURE IN THE RENAL URETER, PERFORMED ON (B)(6) 2019. ON (B)(6) 2019 THE PATIENT HAD A PERCUFLEX PLUS STENT IMPLANTED WITHOUT ANY ISSUES REPORTED. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2019, A PLANNED STENT REMOVAL WAS PERFORMED. DURING ATTEMPTED REMOVAL, THE COIL ON THE KIDNEY SIDE OF THE STENT WAS KINKED NEAR LESS THAN 1 CM FROM THE TIP. IT WAS UNABLE TO BE REMOVED NORMALLY. THE PROCEDURE WAS RESCHEDULED TO THE NEXT DAY DUE TO THE INABILITY TO REMOVE THE STENT. THE FOLLOWING DAY, THE PATIENT UNDERWENT AN ADDITIONAL STENT REMOVAL PROCEDURE. THE PHYSICIAN DELIBERATELY CUT THE COIL OFF OF THE STENT, PRESUMABLY IN ORDER TO ASSIST IN REMOVAL. THE STENT WAS REMOVED FROM THE PATIENT USING FORCEPS AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8743394 ↗
• InjuryDec 4, 2018Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN IMPLANTED PERCUFLEX PLUS STENT WAS EXPLANTED DURING A STENT EXCHANGE AND LITHOTRIPSY FOR STONES PROCEDURE TO BE PERFORMED IN THE KIDNEY AND URETER. THE EXACT DATE OF THIS EVENT WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING STENT REMOVAL, THE PHYSICIAN NOTICED THAT THE COIL OF THE STENT WAS KINKED. ATTEMPTS WERE MADE TO STRAIGHTEN THE COIL AND IN THE PROCESS, THE URETER WAS PERFORATED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Perforation

  MAUDE report 8130924 ↗
• MalfunctionAug 28, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS STENT WAS USED IN A STENT CHANGE PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE STENT PACKAGING WAS NOTICED TO BE OPENED, AND NOT STERILE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PERCUFLEX STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S OUTCOME AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7824976 ↗
• InjuryMar 23, 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 IMPLANTED DURING A TRANSURETHRAL CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN PLACED THE PERCUFLEX¿ PLUS URETERAL STENT AND THEN USED A CYSTOSCOPE TO CHECK THE POSITIONING OF THE STENT. REPORTEDLY, THE RETRIEVAL LINE WAS THOUGHT TO HAVE CUT THROUGH THE STENT, DETACHING THE DISTAL PIGTAIL AND LEAVING IT FREE FLOATING IN THE BLADDER. THE STENT WAS REMOVED FROM THE URETER. SEPARATELY, THE DETACHED PIGTAIL PIECE WAS SUCCESSFULLY REMOVED FROM THE BLADDER USING REMOVAL FORCEPS. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6430054 ↗