Amplatz Super Stiff™ M001465630Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729295754), received between Jan 15, 2019 and Sep 2, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Difficult to Remove

  Patient problems: Pain

  MAUDE report 50569609 ↗
• MalfunctionMay 15, 2025Unraveled Material; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 16APR2025. IT WAS REPORTED THAT COIL WIRE WAS UNRAVELED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE TO EXCHANGE A NEPHROSTOMY DRAINAGE CATHETER. THE NEPHROSTOMY DRAINAGE CATHETER WAS SUCCESSFULLY REMOVED; HOWEVER, THE NEW NEPHROSTOMY DRAINAGE CATHETER WAS UNABLE TO TRACK OVER THE AMPLATZ SUPER STIFF GUIDEWIRE. THE NEPHROSTOMY DRAINAGE CATHETER WAS THEN ABLE TO BE EXCHANGED WITHOUT THE STIFFENER IN THE CORRECT PLACE. UPON EXAMINING THE AMPLATZ SUPER STIFF GUIDEWIRE, IT APPEARED THAT THE THREAD HAD COME AWAY HALFWAY DOWN THE WIRE WHICH HAD MADE THE PROCEDURE MORE CHALLENGING. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COATING WAS PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031093 ↗
• MalfunctionMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA ATTACHED VOLUNTARY MEDWATCH REPORT # MW5169135 THAT WIRE ENTRAPMENT OCCURRED. A 75CM .035 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE WIRE TIP BECAME ENTRAPPED IN THE TRICUSPID VALVE AND WAS UNABLE TO BE RETRIEVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT DUE TO THE PATIENT PRE-EXISTING CONDITION AND THE HIGH RISK ASSOCIATED WITH OPEN-HEART SURGERY, THE DECISION WAS MADE TO LEAVE THE WIRE IN PLACE AND MONITOR THE PATIENT CLOSELY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22009622 ↗
• InjuryMay 5, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE BECAME STUCK IN LESION. MULTIPLE ATTEMPTS TO SNARE AND HYBRID OPERATING ROOM PROCEDURE WERE DONE TO REMOVE THE DEVICE, BUT ALL WERE UNSUCCESSFUL. THE GUIDEWIRE WAS CUT OFF AND REMAINED INSIDE THE PATIENT. THE PATIENT WAS ADMITTED BEYOND THE STANDARD OF CARE AND WILL BE TRANSFERRED TO OTHER FACILITY FOR SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21963430 ↗
• MalfunctionApr 7, 2025Entrapment of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE GUIDEWIRE BECAME ENTRAPPED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR A PERCUTANEOUS NEPHROSTOMY DRAIN EXCHANGE PROCEDURE. THE DEVICE WAS INSERTED AT THE PROXIMAL END OF A NON-BSC NEPHROSTOMY DRAIN. THE DEVICE BECAME STUCK INSIDE THE NON-BSC NEPHROSTOMY DRAIN, AND THE DEVICE'S COATING BECAME LOOSE. BOTH THE NON-BSC NEPHROSTOMY DRAIN, AND DEVICE HAD TO BE REMOVED FROM THE PATIENT TOGETHER. NO FRAGMENTS WERE LEFT INSIDE OF THE PATIENT. A DIFFERENT DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21791259 ↗
• MalfunctionMay 24, 2023Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE PATIENT WAS BEING TREATED WITH ABDOMINAL ABSCESS. THE STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT RENAL ARTERY. A 75CM .035 (BX/5) AMPLATZ SUPER STIFF GUIDEWIRE WAS INSERTED. HOWEVER, THE WIRE WAS TRAPPED WITHIN THE NON-BOSTON SCIENTIFIC DRAINAGE DEVICE WHILE TRYING TO REMOVE. THE DEVICE AND DRAIN REMOVED TOGETHER AND THE PROCEDURE RESTARTED AND COMPLETED WITH DIFFERENT WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16996348 ↗
• MalfunctionMar 15, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED VIA USER FACILITY OR VOLUNTARY MEDWATCH #: (B)(4) THAT REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN INTERNAL JUGULAR VEIN. A 75CM .035 AMPLATZ SUPER STIFF WIRE WAS INSERTED AND PLACED NEAR THE INFERIOR VENA CAVA (IVC). HOWEVER, DURING THIS PROCESS, THE WIRE GOT SLIGHTLY STUCK IN THE TISSUE OF THE RIGHT ATRIUM. THE WIRE WAS PULLED AND RETAINED. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT STATUS WAS STABLE AND NO HARM WAS DONE.

  MAUDE report 13768894 ↗
• MalfunctionJun 2, 2021Unraveled Material; Material Integrity Problem; Unraveled Material; Material Integrity Problem

  IT WAS REPORTED THAT THE GUIDE WIRE COATING PEELED OFF. A 75CM .0 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE; HOWEVER, THE COATING WAS COMING OFF AND THE SPRING COIL WAS UNRAVELLING. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922813 ↗
• MalfunctionMay 4, 2021Difficult to Remove; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. A 75CM AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE IN A DRAINAGE PROCEDURE. UPON REMOVAL FROM PACKAGING, THE DEVICE LOOKED WHOLE AND WAS FLUSHED WITH SALINE. DURING THE PROCEDURE, THE DEVICE WAS USED IN THE KIDNEY. PRIOR TO REMOVING THE DEVICE, THE PHYSICIAN NOTED THAT THE TIP WAS BROKEN INTO SMALL THREADS. IT WAS DIFFICULT TO PULL THE DEVICE OUT, BUT IT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773542 ↗
• MalfunctionMar 25, 2021Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT GUIDEWIRE REMOVAL DIFFICULTY OCCURRED. A 75CM .035 AMPLATZ SUPER STIFF GUIDEWIRE WAS USED FOR A PORT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE GUIDEWIRE BECAME LODGED IN THE PATIENT'S CORONARY. THE PHYSICIAN WAS ABLE TO WITHDRAWAL THE WIRE HOWEVER THE TIP BECAME UNRAVELED. THE PHYSICIAN WAS ABLE TO PULL THE WIRE OUT COMPLETELY AND FEELS THE PATIENT IS RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11569268 ↗
• MalfunctionMar 1, 2021Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15FEB2021. IT WAS REPORTED THAT A 0.035IN X 75CM AMPLATZ SUPER STIFF GUIDEWIRE BECAME STUCK INSIDE A NON-BOSTON SCIENTIFIC SHEATH. WHILE ATTEMPTING TO REMOVE THE WIRE, IT BECAME STRETCHED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE WIRE WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11395220 ↗
• MalfunctionJan 15, 2019Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT CORE WIRE BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE KIDNEY. A 75CM .035 AMPLATZ GUIDEWIRE WAS ADVANCED TO CROSS THE LESION. REMOVAL DIFFICULTY WAS NOTED WHEN REMOVING THE WIRE FROM THE NEPHROSTOMY CATHETER. THE WIRE WAS THEN NOTED TO BE STRETCHED, UNWIND AND CORE WIRE WAS BROKEN. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8246888 ↗