Percuflex™ Plus M0061752730Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729041207), received between Oct 15, 2018 and Oct 17, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 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 PERCUTANEOUS NEPHROLITHOTOMY 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 23331067 ↗
• MalfunctionJul 18, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING INSERTION, THE STENT COULD NOT BE PLACED DUE TO A PROBLEM WITH THE STENT ADVANCER. 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 22548344 ↗
• MalfunctionNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PERCUFLEX PLUS URETERAL STENT WAS IMPLANTED ON (B)(6) 2024. HOWEVER, THE PATIENT DEVELOPED A FEVER AFTER THE PROCEDURE. ON (B)(6) 2024, THE STENT WAS REMOVED FROM THE PATIENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fever

  MAUDE report 20797805 ↗
• MalfunctionMar 7, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A PERCUFLEX PLUS URETERAL STENT WAS OPENED TO BE USED DURING A LASER LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON FEBRUARY 15, 2023. PRIOR TO PROCEDURE, WHEN THE DEVICE WAS UNPACKED, IT WAS NOTED THAT THE STENT HAD DIFFERENT CONSISTENCY THAN USUAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER PERCUFLEX PLUS URETERAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. 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 18861848 ↗
• MalfunctionMay 11, 2021Device-Device Incompatibility; Material Split, Cut or Torn; Device-Device Incompatibility; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A CYSTO, STENT PLACEMENT PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE WIRE SHREDDED IN THE STENT AND HAD TO BE CUT OUT. THE STENT AND WIRE WERE REMOVED WITHOUT INCIDENT FROM THE PATIENT. ANOTHER PERCUFLEX PLUS URETERAL STENT WAS USED TO 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 11809410 ↗
• MalfunctionJan 15, 2021Deformation Due to Compressive Stress; Difficult to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A RIGHT ANTEGRADE URETERIC STENTING PROCEDURE IN THE KIDNEY, URETER AND BLADDER (KUB) PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, , INSIDE THE PATIENT, AFTER MULTIPLE ATTEMPTS OF ADVANCING THE DEVICE, THE PHYSICIAN FOUND THAT THE STENT WAS CRUMBLED. 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. SEE INVESTIGATION FOR RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11178861 ↗
• MalfunctionOct 2, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS OPEN TO BE USED DURING A HOLMIUM LASER LITHOTRIPSY PROCEDURE IN THE URETERAL CALCULUS PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN UNPACKED THE DEVICE, IT WAS NOTICED THAT THE DEVICE WAS FRACTURED. REPORTEDLY THE PROCEDURE WAS COMPLETED. 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 10623313 ↗
• MalfunctionJul 30, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN PERCUFLEX PLUS STENT WAS USED DURING AN URETERAL STENTING PROCEDURE IN THE RIGHT URETER, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE PHYSICIAN NOTICED THAT THE COIL THE STENT WAS DETACHED. ANOTHER PERCUFLEX PLUS STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE STENT SHAFT WAS BROKEN, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8842743 ↗
• MalfunctionMar 18, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS STENT WAS TO BE USED DURING A URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY PROCEDURE, FOR TREATMENT OF RENAL STONES TO BE PERFORMED IN THE KIDNEY, ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTICED THAT THE COIL/PIGTAIL WAS DETACHED AT THE END OF THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER PERCUFLEX PLUS STENT. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8430216 ↗
• MalfunctionOct 15, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS STENT WAS TO BE USED IN A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS HALF SECTION BY THE WIRE. THE PERCUFLEX PLUS STENT WAS NOT USED IN A PATIENT, NOR WAS IT INVOLVED IN A PROCEDURE. 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 7967029 ↗