Percuflex™ Plus M006175253050Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729339977), received between Feb 16, 2018 and Feb 6, 2026 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Calcified” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Nonstandard Device; Deformation Due to Compressive Stress; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED IN A RETROGRADE INTRARENAL SURGERY PROCEDURE IN THE LEFT URETER. DURING THE PROCEDURE, WHEN THE STENT WAS PUSHED THROUGH THE GUIDEWIRE, IT COULD NOT BE SEEN UNDER THE FLUOROSCOPY. THE PHYSICIAN ATTEMPTED TO REPOSITION THE STENT, HOWEVER, ONLY THE GUIDEWIRE CAN BE SEEN UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING THAT THE STENT WAS TORN AND BUCKLED INSIDE THE PATIENT. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284824 ↗
• MalfunctionSep 25, 2024Break; Break

  IT WAS REPORTED THAT, PRIOR TO THE URETERAL PROCEDURE, DURING PREPARATION THE PERCUFLEX PLUS URETERAL STENT BROKE INTO TWO PIECES ALONG THE SHAFT. 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 20306608 ↗
• MalfunctionApr 13, 2021Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT A PERCUFLEX PLUS URETERAL STENT WAS USED, DURING A STENT PLACEMENT PROCEDURE IN THE KIDNEY. FOR KIDNEY STONED PERFORMED ON (B)(6) 2021. DURING PREPARATION, WHEN TRYING TO REMOVE THE SUTURE. THE STENT WAS TORN AND THE COIL WAS DETACHED. ADDITIONALLY, THE STENT SHAFT WAS BROKEN 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. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657812 ↗
• MalfunctionMar 15, 2021Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION WHEN REMOVING THE SUTURE, THE STENT WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT SHAFT BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11488167 ↗
• MalfunctionNov 16, 2020Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A URETERAL STENT PLACEMENT PROCEDURE BETWEEN IN THE KIDNEY AND BLADDER PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE PHYSICIAN SUCCESSFULLY IMPLANTED THE URETERAL STENT, THE POSITION WAS CHECKED THROUGH FLUOROSCOPY. IT WAS NOTICED IN THE X-RAY THAT THE STENT MOVED DUE TO ONE OF THE PIGTAILS WAS STRETCHED. THE PHYSICIAN ATTEMPTED TO MOVE THE STENT BACK TO THE APPROPRIATE POSITION, BUT THE PIGTAIL WAS STRETCHED AND FAILED TO RETURN TO ITS CIRCULAR SHAPE, IT CURLED. THE STENT WAS REMOVED FROM THE PATIENT AND A NON-BSC URETERAL STENT SUCCESSFULLY COMPLETED THE PROCEDURE. PHOTOS OF THE COMPLAINT DEVICE WERE PROVIDED BY THE COMPLAINANT AFTER THE PROCEDURE AND SHOWED THE COIL DETACHED. 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 AND FINE. THE STENT WAS REMOVED FROM THE PATIENT THROUGH THE RIGID URETEROSCOPE AND A NON-BSC URETERAL STENT SUCCESSFULLY COMPLETED THE PROCEDURE.

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

  MAUDE report 10848970 ↗
• InjuryMar 15, 2018Calcified; Difficult to Remove; Calcified; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX¿ PLUS WAS REMOVED FROM THE URETER AND KIDNEY DURING A URETEROSCOPY AND DOUBLE J REMOVAL PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING REMOVAL, IT WAS NOTICED THAT THE STENT WAS ENCRUSTED. IT WAS REPORTED THAT THERE WAS DIFFICULTY IN REMOVING THE STENT, AND IT TOOK MORE THAN TWO HOURS TO REMOVE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE ¿STABLE¿. ATTEMPTS TO GAIN FURTHER INFORMATION REGARDING THE EVENT HAVE BEEN UNSUCCESSFUL TO DATE, SHOULD ANY RELEVANT INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL BE FILED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7341786 ↗
• InjuryMar 5, 2018Calcified; Difficult to Remove; Calcified; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS STENT WAS IMPLANTED IN THE URETER AND KIDNEY ON (B)(6) 2017. IT WAS REMOVED DURING A URETEROSCOPY AND DOUBLE J REMOVAL PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, IT WAS NOTICED THAT THE STENT WAS CALCIFIED. THIS RESULTED IN DIFFICULTY IN REMOVING THE STENT. THE PROCEDURE WAS REPORTED TO HAVE TAKEN MORE THAN TWO HOURS TO COMPLETE. THE ENTIRE STENT WAS REMOVED BY FORCEPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS¿ CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE ¿STABLE¿.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7314353 ↗
• InjuryFeb 16, 2018Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX¿ PLUS STENT WAS TO BE REMOVED FROM THE URETER AND KIDNEY, DURING A URETEROSCOPY AND DOUBLE J PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, IT WAS NOTICED THAT THE STENT WAS CALCIFIED IN THE TAIL OF THE DOUBLE J STENT. IT WAS ALSO REPORTED THAT THE STENT WAS STUCK IN THE RENAL J PELVIS. THE PATIENT WAS SENT TO SURGERY FOR STENT REMOVAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO GAIN FURTHER INFORMATION REGARDING THE EVENT HAVE BEEN UNSUCCESSFUL TO DATE, SHOULD ANY RELEVANT INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL BE FILED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7278919 ↗
• MalfunctionFeb 16, 2018Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX¿ PLUS STENT WAS TO BE REMOVED FROM THE URETER AND KIDNEY, DURING A URETEROSCOPY AND DOUBLE J PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, IT WAS NOTICED THAT THE STENT WAS CALCIFIED IN THE TAIL OF THE STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO GAIN FURTHER INFORMATION REGARDING THE EVENT HAVE BEEN UNSUCCESSFUL TO DATE, SHOULD ANY RELEVANT INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL BE FILED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7278821 ↗
• MalfunctionFeb 16, 2018Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX¿ PLUS STENT WAS TO BE REMOVED FROM THE URETER AND KIDNEY, DURING A URETEROSCOPY AND DOUBLE J PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, IT WAS NOTICED THAT THE STENT WAS CALCIFIED IN THE TAIL OF THE STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO GAIN FURTHER INFORMATION REGARDING THE EVENT HAVE BEEN UNSUCCESSFUL TO DATE, SHOULD ANY RELEVANT INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL BE FILED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7278454 ↗
• MalfunctionFeb 16, 2018Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS STENT WAS TO BE REMOVED FROM THE URETER AND KIDNEY, DURING A URETEROSCOPY AND DOUBLE J PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, IT WAS NOTICED THAT THE STENT WAS CALCIFIED IN THE TAIL OF THE STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO GAIN FURTHER INFORMATION REGARDING THE EVENT HAVE BEEN UNSUCCESSFUL TO DATE, SHOULD ANY RELEVANT INFORMATION BE PROVIDED, A SUPPLEMENTAL MDR WILL BE FILED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7278431 ↗