Percuflex™ Plus M0061752640Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729041191), received between Dec 10, 2018 and Aug 8, 2025 — classified as 1 injury, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Break; Packaging Problem; Break; Packaging Problem

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED IN A LASER LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE, THE STENT WAS FRACTURED. IT WAS NOTED THAT A BEND IN THE PACKAGING HAVE CAUSED THE DAMAGE OF THE STENT. 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 22746406 ↗
• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS OPENED TO BE USED DURING A URETERAL CATHETERIZATION PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE COIL OF THE STENT WAS FOUND FRACTURED. IT WAS NOTED THAT THE STENT WAS BROKEN INTO TWO PIECES ALONG THE SHAFT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18471401 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS TO REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TWO PREVIOUSLY IMPLANTED PERCUFLEX PLUS URETERAL STENT WAS REMOVED FROM THE LEFT AND RIGHT 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 AND RIGHT URETER, AND THE PATIENT WAS PRESCRIBED THE DISCHARGE MEDICATIONS ACETAMINOPHEN (TYLENOL) AND NARCOTIC ANALGESICS (OPIOIDS). NO ISSUES WERE NOTED WITH THE DEVICE. ON (B)(6) 2022, THE PATIENT HAD EXPERIENCED A LEFT AND RIGHT FLANK PAIN. THE PATIENT WAS GIVEN TYLENOL, IBUPROFEN, URINE SAMPLE, 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 APRIL 19, 2022 THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: Pain

  MAUDE report 14458841 ↗
• MalfunctionNov 7, 2021Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY WITH ANTEGRADE STENT PLACEMENT PROCEDURE IN THE KIDNEY AND URETER, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN PLACED THE STENT OVER THE GUIDEWIRE, IT WAS OBSERVED THAT THE STENT WAS BUCKLED. THE PHYSICIAN TRIED TO REMOVE THE WIRE ONCE IDEAL PLACEMENT WAS ACHIEVED, THE WIRE WAS STUCK TO THE STENT AND THE GUIDEWIRE WAS UNABLE TO BE REMOVED. ANOTHER PERCULFEX PLUS URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12759737 ↗
• MalfunctionOct 21, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN PERCUFLEX PLUS URETERAL STENT WAS OPENED TO BE USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN UNPACKED THE PACKAGE, IT WAS NOTICED THAT THE STENT WAS FRACTURED IN TWO PIECES. 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 10714777 ↗
• MalfunctionJul 8, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A URETEROSCOPY WITH STENT PLACEMENT PROCEDURE IN THE URINARY TRACT, KIDNEY TO BLADDER PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE STENT WAS INSERTED, THE PHYSICIAN NOTICED THAT THE BLADDER COIL WOULD NOT PROPERLY FORM A COIL. WHEN THE PHYSICIAN EXAMINED THE STENT VIA THE CAMERA LENS, A TEAR IN THE BLADDER COIL PORTION OF THE STENT WAS NOTICED. REPORTEDLY, THE ASSISTANT PULLED THE SUTURE AND INADVERTENTLY RIPPED THROUGH THE STENT, HOWEVER THE SUTURE REMAINED INTACT. THE STENT ITSELF WAS NOT SEPARATED INTO TWO PIECES. 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 Consequences Or Impact To Patient

  MAUDE report 10244339 ↗
• MalfunctionMay 22, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS STENT WAS TO BE USED FOR A URETEROSCOPY PROCEDURE TO BE PERFORMED IN THE URETER ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE STENT WAS REPORTED TO BE BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER PERCUFLEX PLUS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. 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: No Consequences Or Impact To Patient

  MAUDE report 8633522 ↗
• MalfunctionDec 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS STENT WAS TO BE USED FOR A STENT PLACEMENT PROCEDURE PERFORMED IN THE URETER ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SURGEON NOTED THAT THE DISTAL TIP OF THE STENT WAS DETACHED INSIDE OF THE PATIENT. THE STENT WAS REMOVED TOGETHER WITH THE SCOPE . THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8147383 ↗