Amplatz Super Stiff™ M001465230Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729295716), received between Aug 13, 2019 and Dec 2, 2025 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE DETACHED. THIS AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIODRAINAGE (PTCD) PROCEDURE. DURING THE PROCEDURE, THE AMPLATZ GUIDEWIRE WAS ADVANCED THROUGH A NON-BOSTON SCIENTIFIC SHEATH. DURING MANIPULATION, THE TIP OF THE GUIDEWIRE PEELED OFF INSIDE THE SHEATH. AFTER THIS OCCURRED, THE WIRE COULD NO LONGER BE ADVANCED OR WITHDRAWN. THE PROCEDURE WAS PAUSED, AND THE COMPONENTS WERE REMOVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A GUIDEWIRE FROM ANOTHER MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692186 ↗
• InjurySep 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE SHEARED, BECAME STUCK IN THE PATIENT, REQUIRING INTERVENTION. THIS 035/145 AMPLATZ SUPER STIFF GUIDEWIRE SHEARED AND BECAME STUCK IN THE PATIENT. ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE FRAGMENT, AND IT WAS CONFIRMED VIA XRAY THAT NONE OF THE GUIDEWIRE REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309884 ↗
• InjuryOct 19, 2023Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED RESULTING IN UNRETRIEVED DEVICE FRAGMENTS. A GW/035/145 (BX/5) AMPLATZ SUPER STIFF GUIDEWIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, AFTER INSERTING, THE WIRE COATING BECAME UNRAVELED. KNOTTED, AND BROKE-OFF INSIDE PATIENT. THE FRAGMENT WAS UNABLE TO BE REMOVED. AN ADDITIONAL PROCEDURE WAS SCHEDULED FOR A LATER DATE TO REMOVE THE DETACHED COMPONENT. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17966882 ↗
• MalfunctionAug 15, 2023Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. AN AMPLATZ SUPER STIFF GUIDEWIRE AND FLEXIMA DRAINAGE CATHETER WERE SELECTED FOR USE. DURING THE PROCEDURE, THE FLEXIMA DRAINAGE CATHETER WAS SUCCESSSFULLY PLACED OVER THE AMPLATZ GUIDEWIRE. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE AMPLATZ GUIDEWIRE, IT WAS DIFFICULT TO REMOVE, AND WIRE WAS ENTRAPPED INSIDE THE DRAINAGE CATHETER. THE SPRING TIP OF THE GUIDEWIRE ALSO UNRAVELED. A CLAMP WAS USED TO REMOVE THE DEVICES. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17550226 ↗
• MalfunctionMar 7, 2023Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. A GW/035/145 (BX/1) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE COIL ON THE WIRE CAME AWAY AND POTENTIAL TO LEAVE BITS IN PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497622 ↗
• MalfunctionMar 7, 2023Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. A GW/035/145 (BX/1) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE COIL ON THE WIRE DETACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497314 ↗
• MalfunctionMar 7, 2023Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. A GW/035/145 (BX/1) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE COIL ON THE WIRE DETACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497252 ↗
• MalfunctionMar 7, 2023Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. A GW/035/145 (BX/1) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE COIL ON THE WIRE DETACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496799 ↗
• MalfunctionAug 31, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS BILE DUCT. A 035/145 (BX/5) AMPLATZ SUPER STIFF GUIDEWIRE WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE COATING WAS BULGING OR EXPANDING SLIGHTLY BEFORE THE TIP OF THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327849 ↗
• MalfunctionAug 30, 2022Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS BILE DUCT. A MUSTANG BALLOON CATHETER AND A 035/145 AMPLATZ SUPER STIFF GUIDEWIRE WERE SELECTED FOR USE. HOWEVER, WHEN THE BALLOON CATHETER PASSED THROUGH THE WIRE, IT WAS CAUGHT IN THE WIRE BODY AND WAS UNABLE TO BE INSERTED FURTHER. IT WAS NOTED THAT THE PROXIMAL PART WAS BULGING. BOTH DEVICES WERE REMOVED TOGETHER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321194 ↗
• InjuryOct 17, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED AND THE PROCEDURE WAS PROLONGED. A 035/145 AMPLATZ SUPERSTIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE GUIDEWIRE BECAME STUCK IN "MONO J". THE PHYSICIAN HAD TO REMOVE THE WHOLE SYSTEM AND THE PROCEDURE WHICH WAS SUPPOSED TO LAST 10 MINUTES LASTED 2 HOURS. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED, HOWEVER, THE PATIENT WAS FURTHER HOSPITALIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12644451 ↗
• MalfunctionDec 13, 2019Unraveled Material; Unraveled Material

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29-NOV-2019. IT WAS REPORTED THAT THE GUIDEWIRE UNRAVELED. A 035/145 AMPLATZ SUPER STIFF GUIDEWIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE UNRAVELED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE CORE WIRE WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9470450 ↗
• MalfunctionAug 13, 2019Unraveled Material; Unraveled Material

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16 JUL 2019. IT WAS REPORTED THAT UNRAVELED MATERIAL WAS ENCOUNTERED. A S/S GW/035/145 (BX/1) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE WIRE BECAME UNCOILED. IT DID NOT ENTER INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A COATING PEELING OR SHEARED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8890428 ↗