Amplatz Super Stiff™ M001465020Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729741350), received between Sep 4, 2018 and Sep 15, 2026 — classified as 3 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Unsealed Device Packaging; Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779707 ↗
• MalfunctionFeb 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP WAS TORN OFF AND COULD NOT BE OPENED OCCURRED. A 035/260/3MM (B/1) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. A VISUAL SEPARATION WAS NOTED ON THE DEVICE PRIOR TO USE; THE DISTAL TIP WAS FOUND TORN OFF AND COULD NOT BE OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429584 ↗
• MalfunctionDec 15, 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 19NOV2025. AN 0.035IN X 260CM X 3MM AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING INTRODUCTION, THE GUIDEWIRE COULD NOT CROSS THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED PEELED COATING ON THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23807102 ↗
• MalfunctionDec 3, 2025Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06NOV2025. IT WAS REPORTED THAT THE GUIDEWIRE KINKED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUBCLAVIAN ARTERY. A 035/260/3MM AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE GUIDEWIRE WAS KINKED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THE GUIDEWIRE COATING IS PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23712376 ↗
• MalfunctionDec 3, 2025Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06NOV2025. A 0.035IN X 260CM X 3MM AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE IN A PULMONARY ARTERY EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE GUIDEWIRE WAS FOUND TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE GUIDEWIRE COATING WAS PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23710160 ↗
• MalfunctionAug 26, 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 GUIDEWIRE COATING ISSUE OCCURRED. THE PATIENT UNDERWENT RIGHT ATRIAL APPENDAGE OCCLUSION. A 035/260/3MM AMPLATZ SUPER STIFF WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE THICKNESS OF THE GUIDEWIRE WAS NOT EVEN, AND THE GUIDEWIRE COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE IS A VISIBLE PHYSICAL APPEARANCE OF THE GUIDEWIRE COATING THAT WAS UNEVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894620 ↗
• MalfunctionMar 19, 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 THAT THE BALLOON FROZE ON THE GUIDEWIRE, AND A GUIDEWIRE COATING ISSUE OCCURRED. THIS 035/260/3MM AMPLATZ SUPER STIFF GUIDE WIRE WAS SELECTED FOR USE DURING A PERCUTANEOUS VENOUS STENTING PROCEDURE FOR ILIAC VEIN COMPRESSION. DURING THE PROCEDURE, AFTER THE LOCATION OF THE LESION WAS DETERMINED BY SHEATH ANGIOGRAPHY, THIS 035/260/3MM AMPLATZ SUPER STIFF GUIDE WIRE WAS USED WITH A 10X 80 MUSTANG BALLOON. UPON ADVANCING THE BALLOON, A LARGE RESISTANCE WAS OBSERVED, AND THE BALLOON BECAME STUCK. AT THAT TIME, IT WAS NOTED THAT THERE WAS A SMALL SUBSTANCE FALLING OFF THE GUIDEWIRE, WHICH WAS SUSPECTED TO BE THE COATING. THE GUIDEWIRE COULD NO LONGER BE USED; THEREFORE, THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646219 ↗
• MalfunctionJan 29, 2025Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. A 035/260/3MM AMPLATZ SUPER STIFF WAS SELECTED FOR USE. HOWEVER, AFTER THE GUIDE WIRE WAS IN PLACE, THE FRONT-END COATING FELL OFF WHILE PREPARING TO CROSS THE DEVICE, AND IT COULD NOT ENTER THE BLOOD VESSEL SMOOTHLY. THE GUIDEWIRE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. ACCORDING TO THE PRELIMINARY JUDGMENT, THE REASON FOR THE UNSMOOTH CROSSING AND THEN SCRAPING OFF PART OF THE COATING WAS THAT IT HAD RESISTANCE WHEN ADVANCING THE GUIDEWIRE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266147 ↗
• MalfunctionSep 18, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. THE PATIENT UNDERWENT STENOSIS OF THE LEFT RENAL ARTERY AND STENT IMPLANTATION. A 035/260/3MM (B/5) AMPLATZ SUPER STIFF WAS SELECTED FOR USE. HOWEVER, AFTER UNPACKING, AN EYELASH WAS FOUND IN THE PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246000 ↗
• MalfunctionSep 13, 2024Device Markings/Labelling Problem; Adverse Event Without Identified Device or Use Problem; Device Markings/Labelling Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LABELING ISSUE OCCURRED. A 035/260/3MM (B/5) AMPLATZ SUPER STIFF WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE MODEL ON THE OUTER PACKAGING WAS DIFFERENT FROM THE ONE INDICATED ON THE INNER PACKAGING. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211552 ↗
• MalfunctionApr 25, 2024Device Contaminated During Manufacture or Shipping; Packaging Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem

  IT WAS REPORTED THAT A FOREIGN OBJECT WAS FOUND INSIDE THE PACKAGING. A 035/260/3MM (B/5) AMPLATZ SUPER STIFF WAS SELECTED FOR USE. UPON UNPACKING, DAMAGE WAS NOTED ON THE PACKAGING AND A FOREIGN OBJECT WAS FOUND INSIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182152 ↗
• MalfunctionApr 11, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE PATIENT WAS PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT ARTERIOGRAPHY AND IDIOPATHIC INFLAMMATORY MYOPATHY (IIM) ANGIOPLASTY. A 035/260/3MM AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING PREPARATION, AS THE PHYSICIAN REMOVED THE GUIDEWIRE, IT WAS FOUND THAT THE DEVICE KINKED AND THE TIP BROKE OFF. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16713664 ↗
• MalfunctionJan 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. A 035/260/3MM AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, IT WAS FOUND THAT THE TIP OF THE GUIDEWIRE WAS BROKEN DURING PREPARATION. 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 16233738 ↗
• MalfunctionDec 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DISTAL TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH ATRIAL APPENDAGE CLOSURE. THE TARGET LESION WAS LOCATED IN THE HEART. A 035/260/3MM AMPLATZ SUPER STIFF WIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PLACEMENT OF A WATCHMAN, THE WIRE SPLIT AT THE DISTAL END OF WIRE. THE WIRE WAS REMOVED INTACT AND ANOTHER WATCHMAN WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16006136 ↗
• MalfunctionAug 19, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT AND REMOVAL DIFFICULTIES OCCURRED. A 035/260/3MM AMPLATZ SUPER STIFF GUIDEWIRE WAS INSERTED INTO THE TARGET LESION. HOWEVER, THE GUIDEWIRE BROKE DURING THE PROCEDURE. THE PHYSICIAN TRIED TO MOVE IT BUT COULD NOT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258519 ↗
• MalfunctionAug 5, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT AND REMOVAL DIFFICULTIES OCCURRED. A 035/260/3MM AMPLATZ SUPER STIFF GUIDEWIRE WAS INSERTED INTO THE TARGET LESION. HOWEVER, THE GUIDEWIRE BROKE DURING THE PROCEDURE. THE PHYSICIAN TRIED TO MOVE IT BUT COULD NOT. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15176907 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERICARDIAL EFFUSION, PERFORATION AND CARDIAC TAMPONADE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. THE PATIENT'S ATRIUM WAS NOTED TO BE SMALL AND THE TRANSEPTAL PUNCTURE WAS COMPLEX. AFTER THE TRANSSEPTAL PUNCTURE, AN AMPLATZ SUPER STIFF GUIDEWIRE WAS ADVANCED TO THE LEFT ATRIUM AND IT WAS NOTED A PERICARDIAL EFFUSION OCCURRED. IT WAS INITIALLY MINIMAL AND DURING THE PROCEDURE IT DID NOT INCREASE. THE PROCEDURE CONTINUED AND WAS COMPLETED SUCCESSFULLY WITH A WATCHMAN FLX LAA CLOSURE DEVICE IMPLANTED. ONE DAY POST PROCEDURE, THE PERICARDIAL EFFUSION WAS NOTICED TO HAVE INCREASED SO A PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE BLOOD. THE PATIENT FULLY RECOVERED AND WAS NOT ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 14989186 ↗
• MalfunctionOct 7, 2021Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THE COATING PEELED. AN 035/260/3MM AMPLATZ SS JTIP GUIDEWIRE WAS USED DURING A ATHERECTOMY PROCEDURE. THE AMPLATZ WIRE WAS USED TO REACH A SPECIFIC POINT IN THE PATIENT AND THEN REMOVED. THE DEVICE WAS KEPT IN A TRAY WITH SALINE. AFTER SOME TIME, THE PHYSICIAN TRIED TO REINTRODUCE THE AMPLATZ WIRE AND THE DEVICE COULDN'T GO FURTHER INTO THE 7F INTRODUCER. A SECTION OF ITS LENGTH WAS "PEELED" (THE BLUE COAT OF THE AMPLATZ WAS MISSING). THE PHYSICIAN DID AN IMAGE BUT HE COULDN'T NOTICE ANYTHING IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A PTA COYOTE BALLOON WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590933 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED. DURING A PERSISTENT ATRIAL FIBRILLATION PROCEDURE, THIS EMERGE BALLOON CATHETER ALONG WITH AN AMPLATZ STIFF GUIDWIRE WERE SELECTED. THE DECISION WAS MADE TO CATHETERIZE THE MARSHALL VEIN TO CHECK FOR POSSIBLE ALCOHOLIZATION, BEFORE BEGINNING RECONSTRUCTION OF THE LEFT ATRIUM. THE VEIN COULD BE SEEN UPON CONTRAST INJECTION ON FLUOROSCOPY. THE VEIN WAS THIN AND DIFFICULT TO REACH WITH THE GUIDE CATHETER, THE PHYSICIAN PREFERRED TO GIVE UP THE ALCOHOLIZATION. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH NO DIFFICULTY. HOWEVER, PRIOR TO ABLATION, THE PATIENT BECAME SLIGHTLY HYPOTENSIVE. AN ECHOGRAPHY WAS PERFORMED AND A SMALL CIRCUMFERENTIAL EFFUSION WAS NOTICED AROUND THE RIGHT ATRIUM, WITH NO COMPRESSION OF THE HEART. IN THE MEANTIME, AN ABLATION OF THE POSTERIOR WALL AT THE SUPERIOR VENA CAVA WAS PERFORMED. A SECOND ECHOGRAPHY WAS PERFORMED15 MINUTES LATER, WHICH REVEALED AN INCREASE OF THE EFFUSION. THE PROCEDURE WAS STOPPED AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARDIOLOGIC CARE UNIT WHERE THEY REMAINED STABLE.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 12129489 ↗
• MalfunctionSep 30, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. A 035/260/3MM (B/5) AMPLATZ - PI GUIDEWIRE WAS SELECTED FOR USE; HOWEVER, DURING UNPACKING, IT WAS FOUND THAT THE COATING OF THE GUIDEWIRE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10608327 ↗
• MalfunctionMar 12, 2020Fracture; Fracture

  IT WAS REPORTED THAT GUIDE WIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERIOR PULMONARY VEIN. A 6F EXPO GUIDE CATHETER AND AN AMPLATZ SUPER STIFF GUIDEWIRE WERE SELECTED FOR USE. THE AMPLATZ SUPER STIFF WAS USED FOR THE TRANSSEPTAL SHEATH TO CROSS THE LEFT ATRIUM. DURING THE PROCEDURE WITH THE EXPO, THE TRANSSEPTAL DILATOR WAS REMOVED AND THE EXPO PIGTAIL WAS ADVANCED OVER THE WIRE MIDWAY UP. ONCE THE PIGTAIL WAS TORQUED AT THE TIP OF THE WIRE, IT WAS SEEN THAT THE WIRE HAD SHEARED INTO TWO PARTS. ONE PART OF THE WIRE WAS PROTRUDING FROM THE SIDEWALL OF THE PIGTAIL AND THE OTHER HAD TILT THROUGH THE DISTAL TIP. THE WIRE AND THE CATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9825743 ↗
• MalfunctionJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19-DEC-2019. A 035/260/3MM AMPLATZ SUPER STIFF GUIDEWIRE WAS RETURNED WITH NO REPORTED ALLEGATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THE FOIL SEAL WAS PARTIALLY OPENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9540895 ↗
• MalfunctionOct 29, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGE OF THE DEVICE WAS OPENED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS RECEIVED WITH THE PACKAGE OPENED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9252076 ↗
• MalfunctionOct 29, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGE OF THE DEVICE WAS OPENED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS RECEIVED WITH THE PACKAGE OPENED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9252056 ↗
• MalfunctionOct 29, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGE OF THE DEVICE WAS OPENED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS RECEIVED WITH THE PACKAGE OPENED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9252023 ↗