Amplatz Super Stiff M0066401040Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729752660), received between Apr 2, 2019 and Dec 4, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE URETEROSCOPY PROCEDURE, THE PHYSICIAN TRIED TO PUT THE WIRE THROUGH THE STENT, IT UNRAVELED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED. THE ANALYSIS OF THE RETURNED DEVICE IDENTIFIED CORE WIRE DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720517 ↗
• MalfunctionOct 16, 2024Break; Unraveled Material; Device-Device Incompatibility; Device Contamination with Chemical or Other Material; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Unraveled Material; Device-Device Incompatibility; Device Contamination with Chemical or Other Material; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT DURING PREPARATION OF A RETROGRADE INTRARENAL SURGERY, WHEN THE GUIDEWIRE WAS PUSHED INTO THE SCOPE, THE COIL OF THE GUIDEWIRE HAS UNWOUND AFTER APPLYING FORCE BECAUSE OF THE FEELING OF FOREIGN MATTER. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THERE WAS NO FOREIGN MATERIAL PRESENT AT ANY POINT. REPORTEDLY, THE SOFT TIP OF GUIDEWIRE WAS SLIGHTLY BENT, AND THE COIL OF THE GUIDEWIRE WAS NOTED UNWOUND UPON REMOVAL FROM SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT PATIENT COMPLICATIONS. THE PATIENT OUTCOME FOLLOWING THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20464772 ↗
• MalfunctionAug 8, 2024Detachment of Device or Device Component; Device-Device Incompatibility; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Device-Device Incompatibility; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AMPLATZ SUPER STIFF WAS USED IN THE PROCEDURE. WHEN PUSHING THE GUIDEWIRE TO MOUNT ONTO THE STENT, THE GUIDEWIRE BROKE OFF AFTER APPLYING FORCE DUE TO THE FEELING OF HAVING A FOREIGN MATTER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940241 ↗
• MalfunctionAug 31, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF GUIDEWIRE WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CORE WIRE BROKE AND DID NOT GO UP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17660765 ↗
• MalfunctionNov 29, 2022Break; 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 WAS USED DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE COIL LOOSENS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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: THE COREWIRE WAS BROKEN APPROXIMATELY SEVEN CM FROM THE DISTAL TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882338 ↗
• MalfunctionNov 4, 2021Detachment 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 PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. DURING THE PROCEDURE, WHEN PHYSICIAN INTRODUCES THE WIRE, THE COIL WIRE WAS BROKEN/FRACTURED AND STAFF NOTICED SILVER FRAGMENTS ON THE MONITOR. 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 12751207 ↗
• MalfunctionMar 7, 2021Break; Unraveled Material; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Unraveled Material; 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 GUIDEWIRE WAS USED IN THE KIDNEYS DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE ON (B)(6) 2020. DURING THE PROCEDURE, THE AMPLATZ GUIDEWIRE WAS UNRAVELED. THE PROCEDURE WAS COMPLETED WITH ANOTHER AMPLATZ SUPER STIFF GUIDEWIRE. THERE WERE NO REPORTED PATIENT COMPLICATIONS 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 REPORTABLE BASED ON THE INVESTIGATION RESULTS OF COREWIRE AND COIL WIRE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426497 ↗
• MalfunctionJul 14, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF GUIDEWIRE WAS USED IN A PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE AMPLATZ COREWIRE BROKE IN THE MID-URETER. IT IS UNKNOWN HOW THE PROCEDURE COMPLETED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10271741 ↗
• MalfunctionFeb 13, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AMPLATZ GUIDEWIRE WAS USED IN THE KIDNEY DURING A STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE GUIDEWIRE COATING UNRAVELED. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ GUIDEWIRE. 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 RESULTS OF COREWIRE BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9707365 ↗
• MalfunctionDec 31, 2019Break; Unraveled Material; Material Deformation; Break; Unraveled Material; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF GUIDEWIRE WAS USED DURING A PLACEMENT OF URETERAL STENT VIA GUIDEWIRE AND OPEN LAPAROTOMY PROCEDURE PERFORMED IN (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE PHYSICIAN WAS PLACING A URETERAL STENT, HE MADE A HIGH URETHROTOMY INCISION TO PASS A 5-FRENCH ANGLE-TIPPED URETERAL CATHETER DOWN THE URETER INTO THE BLADDER. VIA CYSTOSCOPY, HE PASSED AN AMPLATZ GUIDEWIRE UP TO THE URETER. THE GUIDEWIRE WAS BACKLOADED IN THE CYSTOSCOPE AND OVER THE WIRE, STENT WAS PLACED. THE STENT WAS DIFFICULT TO ADVANCE AND FELT THAT THE GUIDEWIRE WAS BENT. WHEN THE GUIDEWIRE WAS REMOVED, IT BROKE AND UNRAVELED. UPON INSPECTION OF THE WIRE BY THE SURGEON, HE FELT IT HE HAD ALL THE PIECES. X-RAY SHOWED NO FOREIGN BODY IN THE AREA EXCEPT THE INTENDED URETERAL STENT. HOWEVER, POST EVALUATION BY THE UROLOGIST IDENTIFIED THE PROXIMAL END OF THE STENT IS BENT OVER ON ITSELF AND WILL NEED TO BE REMOVED AT A LATER DATE WITH POSSIBLE REPLACEMENT NEEDED IN 6-12 WEEKS. REPORTEDLY, THE INITIAL SURGERY FOR PELVIC MASS REMOVAL WAS A LAPAROSCOPIC APPROACH. HOWEVER, UPON ENTERING THE ABDOMINAL CAVITY, THE SIZE OF THE MASS COU

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9535520 ↗
• MalfunctionSep 20, 2019Break; Unraveled Material; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Break; Unraveled Material; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF GUIDEWIRE WAS USED IN THE RIGHT URETER DURING A CYSTOURETHROSCOPY, URETEROSCOPY, RETROGRADE PYELOGRAM, INSERTION OF RIGHT DOUBLE J URETERAL STENT AND DILATION OF MEATAL STENOSIS PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE AMPLATZ GUIDEWIRE WAS DIFFICULT TO ADVANCE AND APPEARED UNRAVELED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT GUIDEWIRE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9098930 ↗
• MalfunctionApr 2, 2019Break; Unraveled Material; Break; Unraveled Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ GUIDEWIRE WAS USED DURING AN PCNL (PERCUTANEOUS NEPHROLITHOTOMY) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDEWIRE UNRAVELED. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ GUIDEWIRE. 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. 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 8475185 ↗