Amplatz Super Stiff M0066401060Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729752684), received between Apr 6, 2017 and Dec 27, 2024 — classified as 1 death, 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2024Nonstandard Device; Difficult to Remove; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Difficult to Remove; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE METAL COATING ON THE WIRE UN-WOUND AND GOT STUCK IN THE PATIENT IT WAS ATTEMPTED TO REMOVE IT BUT IT WAS TOO DIFFICULT. THEREFORE, A FOLLOWING PROCEDURE WILL BE PERFORMED TO REMOVE THE PART OF THE DEVICE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027930 ↗
• MalfunctionMar 21, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF WAS USED IN A PROCEDURE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY HAD TROUBLE WITH THE BSC BASKET, AND THAT THE WIRE SPLIT. REPORTEDLY, THE BASKET WAS EITHER AN ESCAPE BASKET 390-201 OR A 3FR ZERO TIP 390-103. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. 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 8441179 ↗
• DeathOct 4, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF UROLOGY GUIDEWIRE WAS USED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) DURING A LOWER EXTREMITY ANGIOGRAM PROCEDURE PERFORMED ON (B)(6) 2018. PER THE DEVICE'S DIRECTIONS FOR USE (DFU) IT STATES THAT THE AMPLATZ UROLOGY GUIDEWIRE IS NOT INTENDED FOR CORONARY OR VASCULAR USE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE AMPLATZ SUPER STIFF UROLOGY GUIDEWIRE AND THE CATHETER (MANUFACTURER UNKNOWN) GOT STUCK. THE AMPLATZ SUPER STIFF UROLOGY GUIDEWIRE BECAME SHREDDED, AND THE TIP OF THE CATHETER BROKE OFF IN THE PATIENT. THE DETACHED PORTION OF THE CATHETER TIP WAS RETRIEVED FROM THE PATIENT. REPORTEDLY, THE CATHETER WAS NOT A BSC PRODUCT. THE PATIENT'S ILIAC ARTERY WAS APPARENTLY TORN, AND THE CAUSE IS UNKNOWN. THE PATIENT BLED OUT AND DIED. IT IS UNKNOWN IF THE DEVICES WERE RELATED TO THE CAUSE OF DEATH. 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: Death; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7933555 ↗
• MalfunctionJul 27, 2018Break; 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, THE AMPLATZ GUIDEWIRE WAS SHREDDED. 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. INVESTIGATION RESULTS REVEALED ON (B)(6) 2018 THAT THE CORE WIRE SEPARATED FROM THE WELDING BALL ON ITS DISTAL END.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7726882 ↗
• MalfunctionJul 21, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SUPER STIFF GUIDEWIRE WAS USED IN THE URETER DURING A URETEROSCOPY PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN THE PHYSICIAN OPENED THE PACKAGING, IT WAS FOUND THAT THE GUIDEWIRE WAS BROKEN THROUGH THE COIL OVERLAY. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ SUPER STIFF 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 FINE. INVESTIGATION RESULTS REVEALED ON (B)(6) 2017 THAT THE GUIDEWIRE WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6731828 ↗
• MalfunctionApr 6, 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, THE GUIDEWIRE KINKED AND THE TEFLON COATING UNRAVELED CAUSING IT TO KNOT IN THE URETER AND EXPOSED THE METAL CORE WIRE. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ SUPER STIFF¿ 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 FINE. INVESTIGATION RESULTS REVEALED ON (B)(6) 2017 THAT THE CORE WIRE IS BROKEN AT 138 CM FROM THE PROXIMAL SECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6464558 ↗