Percuflex™ Plus M006175254050Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729170082), received between Nov 14, 2017 and Mar 15, 2018 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Calcified” (15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 PATIENTS¿ 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 7341875 ↗
• InjuryMar 1, 2018Calcified; Difficult to Remove; Calcified; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX¿ PLUS STENT WAS PREVIOUSLY IMPLANTED IN THE URETER AND KIDNEY ON (B)(6) 2017. IT WAS REMOVED DURING A URETEROSCOPY AND DOUBLE J PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING REMOVAL, IT WAS NOTICED THAT THE STENT WAS ENCRUSTED. IT WAS REPORTED THAT DIFFICULTY IN REMOVING THE STENT WAS ENCOUNTERED, AND IT TOOK MORE THAN TWO HOURS TO REMOVE. A CYSTOLITHOLAPAXY WAS DONE TO BREAK UP THE ENCRUSTATION AND THE ENTIRE STENT WAS REMOVED WITH THE USE OF FORCEPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENTS¿ CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE ¿STABLE¿.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7307967 ↗
• 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 7278952 ↗
• InjuryFeb 16, 2018Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEXPLUS 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 7278873 ↗
• 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 7278466 ↗
• 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 7278426 ↗
• 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 7278411 ↗
• MalfunctionNov 15, 2017Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS STENT WAS USED IN THE URETER AND KIDNEY DURING A URETEROSCOPY AND DOUBLE J PLACEMENT PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, IT WAS NOTED THAT THE STENT WAS CALCIFIED IN THE TAIL OF THE DOUBLE J 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 7033823 ↗
• InjuryNov 15, 2017Calcified; Difficult to Remove; Calcified; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS STENT WAS USED IN THE URETER AND KIDNEY, DURING A URETEROSCOPY AND DOUBLE J PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST 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 REMOVAL OF THE STUCK 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 7033784 ↗
• InjuryNov 15, 2017Calcified; Difficult to Remove; Calcified; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS STENT WAS USED IN THE URETER AND KIDNEY, DURING A URETEROSCOPY AND DOUBLE J PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST 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 REMOVAL OF THE STUCK 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 7033760 ↗
• MalfunctionNov 15, 2017Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX¿ PLUS STENT WAS USED IN THE URETER AND KIDNEY DURING A URETEROSCOPY AND DOUBLE J PLACEMENT PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, IT WAS NOTED THAT THE STENT WAS CALCIFIED IN THE TAIL OF THE DOUBLE J 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 7033740 ↗
• MalfunctionNov 15, 2017Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX¿ PLUS STENT WAS USED IN THE URETER AND KIDNEY DURING A URETEROSCOPY AND DOUBLE J PLACEMENT PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, IT WAS NOTED THAT THE STENT WAS CALCIFIED IN THE TAIL OF THE DOUBLE J 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 7033357 ↗
• MalfunctionNov 15, 2017Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS STENT WAS USED IN THE URETER AND KIDNEY DURING A URETEROSCOPY AND DOUBLE J PLACEMENT PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, IT WAS NOTED THAT THE STENT WAS CALCIFIED IN THE TAIL OF THE DOUBLE J 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 7033128 ↗
• MalfunctionNov 14, 2017Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS STENT WAS USED IN THE URETER AND KIDNEY DURING A URETEROSCOPY AND DOUBLE J PLACEMENT PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, IT WAS NOTED THAT THE STENT WAS CALCIFIED IN THE TAIL OF THE DOUBLE J 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 7031462 ↗
• MalfunctionNov 14, 2017Calcified; Calcified

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PERCUFLEX PLUS STENT WAS USED IN THE URETER AND KIDNEY DURING A URETEROSCOPY AND DOUBLE J PLACEMENT PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, IT WAS NOTED THAT THE STENT WAS CALCIFIED IN THE TAIL OF THE DOUBLE J 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 7031450 ↗