Amplatz Super Stiff™ M001465090Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 08714729295655), received between Jun 29, 2019 and Aug 28, 2026 — classified as 1 injury, 63 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (19 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 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508394 ↗
• MalfunctionJul 29, 2026Nonstandard Device; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50068757 ↗
• MalfunctionJun 24, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 035/260/1 AMPLATZ SUPER STIFF WAS SELECTED FOR USE. DURING DEVICE PREPARATION, THE WIRE WAS RINSED WITH SALINE OUTSIDE THE PATIENT. HOWEVER, THE TIP DETACHED WHEN IT WAS SHAPED. THE DEVICE WAS EXCHANGED PRIOR TO INTRODUCTION TO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25610845 ↗
• MalfunctionJan 15, 2026Nonstandard Device; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE HAD BECOME DETACHED. THE PROCEDURE INVOLVED AN ATRIAL SEPTAL DEFECT (ASD), AND A 035/260/1 (BX/1) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING DELIVERY, SIGNIFICANT RESISTANCE PREVENTED THE ADVANCEMENT OF THE GUIDEWIRE. UPON REMOVAL, IT WAS DISCOVERED THAT THE TIP OF THE GUIDEWIRE HAD DETACHED AND BECOME INCOMPLETE DUE TO A DETACHMENT OF ITS LOOP; HOWEVER, IT DID NOT BREAK. THE PATIENTS ANATOMY WAS NOT CONSIDERED CHALLENGING, AND NEITHER PATIENT NOR PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED EVENT. THE LESION EXHIBITED NO STENOSIS, TORTUOSITY, OR CALCIFICATION. THE DEVICE WAS REMOVED BY PULLING IT OUT DIRECTLY, WITH NO FRAGMENT LEFT INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE, AND NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079769 ↗
• MalfunctionDec 3, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06NOV2025. THE TARGET LESION WAS LOCATED IN THE COLON. A 035/260/1 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE WAS USED TO ESTABLISH A CHANNEL TO THE COLON. THE STENT ENTERED ALONG THE GUIDEWIRE. HOWEVER, THE MIDDLE POSITION OF THE GUIDEWIRE WAS STUCK, AND THE STENT COULD NOT ENTER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE GUIDEWIRE COATING IS PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708880 ↗
• MalfunctionSep 18, 2025Difficult to Insert; Material Integrity Problem; Difficult to Insert; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUES OCCURRED. AN AMPLATZ SUPER STIFF WAS SELECTED FOR USE DURING THIS THROMBUS ASPIRATION IN DEEP VEIN THROMBOSIS OF LOWER EXTREMITIES PROCEDURE. PRIOR TO THE PROCEDURE, WHEN THE PHYSICIAN OPENED THE OUTER PACKAGE AND PULLED OUT THE DEVICE, IT WAS NOTED THAT THERE WERE BURRS ON THE GUIDEWIRE AND HAD A DISTINCT TACTILE SENSATION. THE WIRE COULD NOT ENTER THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084258 ↗
• MalfunctionAug 26, 2025Unraveled Material; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30JUL2025. IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE WAS BIFURCATED. THE TARGET LESION WAS LOCATED IN THE CARDIAC CONDUCTION BLOCK. AN AMPLATZ SUPER STIFF GUIDE WIRE WAS SELECTED FOR USE IN A PERMANENT PACEMAKER IMPLANTATION. UPON UNPACKING, IT WAS FOUND THAT THE TIP OF THE GUIDEWIRE WAS BIFURCATED; THE GUIDEWIRE BODY AT THE TIP OF THE GUIDEWIRE WAS SEPARATED FROM THE COIL. IT APPEARS THE FLAT WIRE COIL UNRAVELED FROM THE CORE WIRE AT THE TIP OF THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THE CORE WIRE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22899336 ↗
• MalfunctionAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 035/260/1 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE SPRING TIP OF THE GUIDEWIRE CAME OFF. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897139 ↗
• MalfunctionJul 1, 2025Difficult to Flush; Fracture; Adverse Event Without Identified Device or Use Problem; Difficult to Flush; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEWIRE SPLIT APART. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING PREPARATION, THE GUIDEWIRE COULD NOT BE FLUSHED AND SPLIT APART. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22374886 ↗
• MalfunctionJun 17, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE WIRE WAS DIFFICULT TO REMOVE. DURING THE PROCEDURE, THIS AMPLATZ SUPER STIFF WIRE WAS DIFFICULT TO REMOVE. THE WIRE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING ANOTHER AMPLATZ WITHOUT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236062 ↗
• MalfunctionJun 9, 2025Detachment 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 THAT TIP DETACHMENT OCCURRED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE TWO FIBERS WERE PROTRUDING NEAR THE TIP OF THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168860 ↗
• MalfunctionJun 5, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE WIRE COATING WAS PEELING OFF. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED ILIAC VEIN. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR VENOUS THROMBECTOMY PROCEDURE. WHEN THE WIRE WAS INSERTED IN THE WIRE LUMEN OF THE 13F NON-BOSTON SCIENTIFIC SHEATH, IT FELT VERY TIGHT, AND THE COATING NEAR THE PROXIMAL END APPEARED TO BE PEELING OFF. THE SYSTEM WAS REMOVED, AND FOUND THE ENTIRE LENGTH OF THE WIRE COATING WAS PEELED OFF. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ WIRE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150669 ↗
• MalfunctionMar 21, 2025Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23FEB2025. IT WAS REPORTED THAT TIP DAMAGE OCCURRED. THE 90% TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. DURING PROCEDURE, A DAMAGE WAS OBSERVED AT THE TIP OF THE PRODUCT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED CORE WIRE DETACHED AND SEPARATED FROM DISTAL TIP TO THE TRANSITION POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663018 ↗
• MalfunctionMar 6, 2025Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THE DEVICE MATERIAL SEPARATED AND DETACHED INSIDE OF THE PATIENT. THE 60% STENOSED, MODERATELY CALCIFIED AND TORTUOUS TARGET LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) TO TREAT AN OCCLUSION. A AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR A THROMBECTOMY PROCEDURE. THE DISTAL SECTION OF THE DEVICE MATERIAL SEPARATED. THE DEVICE WAS REMOVED AND NO FRAGMENTS WERE LEFT INSIDE OF THE PATIENT. A DIFFERENT DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542352 ↗
• MalfunctionNov 21, 2024Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE COATING WAS DAMAGED. THIS 035/260/1 (BX/5) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE DURING A CAROTID INTERVENTION PROCEDURE. DURING THE PROCEDURE, WHILE INSERTING THE GUIDEWIRE INTO THE SHEATH, IT WAS NOTICED THAT THE COATING ON THE PROXIMAL END OF THE GUIDEWIRE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE COATING ON THE WIRE HAD SHIFTED AND BECAME BUMPY AT THE MIDDLE AND END OF THE BODY OF THE WIRE. THE WIRE WAS IN THE PATIENTS BODY WITH A DIAGNOSTIC CATHETER AND BECAME STUCK. THE CATHETER AND WIRE WERE REMOVED FROM THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20749807 ↗
• MalfunctionOct 1, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT GUIDEWIRE PEELING OCCURRED. THE TARGET LOCATION WAS IN THE LEFT ATRIAL APPENDAGE. A 035/260/1 (BX/5) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR TREATMENT. THE DEVICE WAS UNPACKED AND DURING PREPARATION, IT WAS FOUND THAT THE MIDDLE PART OF THE DEVICE WAS PEELING. NO FRAGMENT WAS LEFT INSIDE THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345186 ↗
• MalfunctionAug 28, 2024Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COATING HAD PEELED. AN AMPLATZ - PI GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DISTAL END OF THE COATING WAS IRREGULAR AND ROUGHENED. THE GUIDEWIRE WAS DETERMINED TO BE UNUSABLE AND WAS REPLACED WITH A NEW GUIDEWIRE, SAME MODEL TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20084855 ↗
• MalfunctionMay 1, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01APR2024. IT WAS REPORTED THAT THE CORE WIRE PROTRUDED FROM THE TIP. THE PATIENT PRESENTED WITH ATRIAL SEPTAL DEFECT (ASD). A 035/260/1 (BX/1) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE IN THE CLOSURE PROCEDURE. FLUSHING WAS PERFORMED WITH SALINE AFTER THE WIRE WAS UNPACKED DURING CASE PREPARATION. HOWEVER, WHEN SHAPING WAS PERFORMED ON THE TIP, IT WAS OBSERVED THAT THE CORE WIRE CAME OUT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE CORE WIRE SEPARATED FROM BALD SOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221744 ↗
• MalfunctionApr 5, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT WIRE ENTRAPMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 035/260/1 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE NON-BOSTON SCIENTIFIC BALLOON AND THE WIRE WERE CRIMPED AND BOTH DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050712 ↗
• MalfunctionApr 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 035/260/1 (BX/1) AMPLATZ SUPER STIFF WAS SELECTED FOR USE FOR A MITRACLIP CASE. DURING UNPACKING, IT WAS NOTED THAT THE TIP HAD BEEN CHIPPED. THE DEVICE WAS NOT USED IN THE PATIENT AND 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 19035011 ↗
• MalfunctionMar 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 035/260/1 (BX/1) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. THE DEVICE WAS UNPACKED AND ATTEMPTED TO BE INSERTED INTO THE SHEATH, THE TIP WAS NOTED TO BE CHIPPED. A SECOND GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899128 ↗
• MalfunctionSep 22, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT GUIDEWIRE PEELING OFF OCCURRED. THE PATIENT PRESENTED WITH LOWER LIMB PERIPHERAL ARTERY DISEASE (PAD). THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILLIAC ARTERY. A 035/260/1 (BX/1) AMPLATZ SUPER STIFF GUIDE CATHETER WAS USED FOR TREATMENT. HOWEVER, DURING INSERTION, A BLACK POLYMER PART OF THE GUIDEWIRE SPRING COIL TIP PEELED OFF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THE DEVICE WAS REMOVED INTACT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17800083 ↗
• MalfunctionJun 26, 2023Failure to Advance; Material Integrity Problem; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED THAT GUIDEWIRE COATING ISSUE OCCURRED. A 035/260/1 AMPLATZ SUPER STIFF GUIDEWIRE WAS ADVANCED TO ASSIST A BALLOON TO CROSS THE STENOSIS. SUBSEQUENTLY, PRE-DILATATION WAS PERFORMED. HOWEVER, THE GUIDEWIRE COULD NOT CROSS THE VASCULAR STENOSIS. WHEN THE GUIDEWIRE WAS REMOVED, IT WAS OBSERVED THAT THE FRONT COATING OF THE GUIDEWIRE WAS PEELING OFF AND THERE WERE SMALL PROTRUSIONS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199973 ↗
• MalfunctionJun 26, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT GUIDEWIRE COATING ISSUE OCCURRED. A 035/260/1 AMPLATZ SUPER STIFF GUIDEWIRE WAS USED AND CROSSED THE LESION. HOWEVER, THE PRODUCT WAS DEFECTIVE, AND WAS NOT WORKING PROPERLY. IT WAS ALSO NOTED THE COATING OF THE GUIDEWIRE SHEARED OFF. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199963 ↗
• MalfunctionApr 20, 2023Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DEVICE CONTAMINATION WAS ENCOUNTERED. A 035/260/1 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, BEFORE THE DEVICE WAS OPENED, IT WAS NOTED, THAT THE TIP OF THE HOOP GOT STUCK INTO THE ADHESIVE PART OF THE PACKAGING BAG AND IT HAD A HOLE. CONSEQUENTLY, THE STERILITY OF THE DEVICE WAS NOT MAINTAINED. IT WAS NOTED, THAT THE DEVICE WAS PLACED IN THE OUTER BOX DURING DELIVERY AND WAS STORED ON THE SHELF OF THE CATHETERIZATION ROOM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781281 ↗