Amplatz Super Stiff M0066401080Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729752707), received between May 9, 2017 and May 1, 2026 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, AN AMPLATZ SUPER STIFF WAS USED, THE GUIDEWIRE WAS SHREDDED UPON OPENING DURING A CASE. THE GUIDEWIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062215 ↗
• InjuryFeb 21, 2024Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AMPLATZ SUPER STIFF WAS USED TO TREAT KIDNEY STONES DURING A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WAS NOT ADVANCING PROPERLY. THE GUIDEWIRE WAS REMOVED, AND IT WAS NOTICED THE POLYTETRAFLUOROETHYLENE (PTFE) COATING PEELED OFF EXPOSING THE STAINLESS-STEEL CORE, HOWEVER IT WAS STILL ATTACHED TO THE CORE WIRE. ANOTHER GUIDEWIRE WAS ATTEMPTED TO BE USED, HOWEVER, THERE WAS DIFFICULTY ADVANCING THE GUIDEWIRE AND FOUND THAT IT WAS BUCKLED AT THE TIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SENSOR WIRE. THE PHYSICIAN SUSPECTED URETHRAL PERFORATION OF THE PATIENT AFTER USE OF THE FIRST GUIDEWIRE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Perforation

  MAUDE report 18745398 ↗
• InjuryJul 10, 2023Break; Unraveled Material; Adverse Event Without Identified Device or Use Problem; Break; Unraveled Material; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE ON JUNE 15, 2023. DURING THE PROCEDURE, WHEN THE GUIDEWIRE WAS PLACED INSIDE THE PATIENT, IT UNRAVELED, AND THE CORE WIRE BROKE. REPORTEDLY, THE BROKEN TIP WAS RETRIEVED. THE PHYSICIAN USED A SECOND AMPLATZ GUIDEWIRE, AND THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND 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 17292117 ↗
• InjuryJul 7, 2023Break; Unraveled Material; Adverse Event Without Identified Device or Use Problem; Break; Unraveled Material; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE GUIDEWIRE WAS PLACED INSIDE THE PATIENT, IT UNRAVELED, AND THE CORE WIRE BROKE. REPORTEDLY, THE BROKEN TIP WAS RETRIEVED. THE PHYSICIAN USED A SECOND AMPLATZ GUIDEWIRE, AND THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND 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 17282900 ↗
• InjuryMay 5, 2023Unraveled Material; Use of Device Problem; Detachment of Device or Device Component; Unraveled Material; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED DURING A LEFT ARM ARTERIOVENOUS FISTULA (AVF) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PROCEDURE, THE TIP OF THE AMPLATZ WIRE UNRAVELED AND DETACHED. IN ADDITION, THE AVF VESSEL WAS ALSO PERFORATED. A SNARE WAS USED TO RETRIEVE THE DETACHED TIP OF WIRE AND STENT WAS PLACED TO STOP BLEEDING FROM WIRE PERFORATION. PER PHYSICIAN'S OPINION, THE AMPLATZ WIRE CAUSE OR CONTRIBUTE TO THE PATIENT'S PERFORATION. IT WAS REPORTED THAT THE PATIENT WAS FULLY RECOVERED. NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT THE AMPLATZ SUPER STIFF GUIDEWIRE IS INTENDED TO FACILITATE THE PLACEMENT OF ENDOUROLOGICAL INSTRUMENTS DURING DIAGNOSTIC OR INTERVENTIONAL PROCEDURES AND NOT INTENDED FOR CORONARY ARTERY, VASCULAR OR NEUROLOGICAL USE; HOWEVER, THE AMPLATZ WIRE WAS USED TO FACILITATE PLACEMENT IN THE LEFT ARM ARTERIOVENOUS FISTULA FOR THIS CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16878166 ↗
• MalfunctionApr 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. DURING PROCEDURE, THE PHYSICIAN OBSERVED THAT THE COIL WIRE WAS DETACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16745732 ↗
• MalfunctionApr 10, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE ON (B)(6) 2023. DURING PROCEDURE, THE PHYSICIAN OBSERVED THAT THE COIL WIRE WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ SUPER STIFF GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16708756 ↗
• MalfunctionFeb 20, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED DURING A STONE REMOVAL. THE PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, UPON EXTRACTION FROM THE URETHRAL CATHETER, THE AMPLATZ WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ SUPER STIFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16405852 ↗
• MalfunctionJan 20, 2023Break; Unraveled Material; Break; Unraveled Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED DURING AN URETEROSCOPY PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE GUIDEWIRE WAS PLACED INSIDE PATIENT, IT UNRAVELED, AND THE CORE WIRE BROKE. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ SUPER STIFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218764 ↗
• MalfunctionAug 10, 2022Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF AS BEING USED IN AN INTERVENTIONAL RADIOLOGY PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, THE GUIDEWIRE WAS STIFF. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15198201 ↗
• MalfunctionJul 26, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF AS BEING USED IN A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, THE COATING CAME OFF THE WIRE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15102429 ↗
• InjuryApr 15, 2022Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ WIRE WAS USED IN KIDNEY DURING A PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, THE GUIDEWIRE UNCOILED AND COILWIRE BROKE. THE PHYSICIAN WAS ABLE TO GRASP THE DETACHED PORTION AND REMOVED IT FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14118956 ↗
• MalfunctionJan 6, 2021Break; Unraveled Material; Break; Unraveled Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF GUIDEWIRE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6)2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE AMPLATZ SUPER STIFF GUIDEWIRE WAS USED TO ACCESS INTO THE KIDNEY. HOWEVER, WHEN THE PHYSICIAN RETRACTED THE AMPLATZ SUPER STIFF GUIDEWIRE, IT UNRAVELED. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ SUPER STIFF GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: CORE WIRE WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11124633 ↗
• MalfunctionDec 8, 2020Break; Unraveled Material; Adverse Event Without Identified Device or Use Problem; Break; Unraveled Material; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AMPLATZ SUPER STIFF GUIDEWIRE WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE AMPLATZ GUIDEWIRE WAS UNRAVELED. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ SUPER STIFF GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: COREWIRE WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10969446 ↗
• MalfunctionMar 17, 2020Break; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Break; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AMPLATZ GUIDEWIRE WAS USED IN THE URETER DURING URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE GUIDEWIRE WAS WITHDRAWN, THE PHYSICIAN NOTICED THAT THE COATING HAD COME OFF APPROXIMATELY TWO INCHES IN LENGTH. REPORTEDLY, THE DETACHED COATING WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED THIS GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: COREWIRE BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9841251 ↗
• MalfunctionAug 7, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF GUIDEWIRE WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, ¿DURING THE PROCEDURE, PHYSICIAN SPLIT THE AMPLATZ SUPER STIFF WIRE IN TWO WHILE REMOVING DURING STENT INSERTION.¿ THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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 Known Impact Or Consequence To Patient

  MAUDE report 6771167 ↗
• MalfunctionJun 22, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF¿ GUIDEWIRE WAS USED IN THE URETER DURING A RETROGRADE INTRARENAL SURGERY PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER PLACEMENT OF THE STENT INTO THE URETER USING THE PUSHER THROUGH THE CYSTOSCOPE, RESISTANCE WAS MET WHEN THE AMPLATZ GUIDEWIRE WAS PULLED OUT FROM THE PUSHER. THE PUSHER AND THE AMPLATZ GUIDEWIRE WERE REMOVED TOGETHER AND IT WAS FOUND THAT THE COIL WIRE OF THE GUIDEWIRE WAS UNRAVELED. THE PROCEDURE WAS COMPLETED WITH THIS 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 STABLE. INVESTIGATION RESULTS REVEALED ON MAY 29, 2017 THAT THE CORE WIRE IS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6660162 ↗
• MalfunctionMay 9, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF¿ GUIDEWIRE WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDEWIRE STRIPPED WHEN IT WAS PULLED OUT OF THE SCOPE. 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. INVESTIGATION RESULTS REVEALED ON (B)(6) 2017 THAT THE CORE WIRE IS BROKEN AT DISTAL SECTION END.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6553533 ↗