Amplatz Super Stiff™ M001465010Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729295648), received between Feb 12, 2020 and Sep 26, 2025 — classified as 2 deaths, 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• DeathSep 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED VIA ATTACHED VOLUNTARY MEDWATCH REPORT #MW5175144. THE PATIENT WAS TRANSFERRED ON (B)(6) AFTER PRESENTING WITH STROKE SYMPTOMS. THE PATIENT BECAME BRADYCARDIC, AND THEIR NATIONAL INSTITUTES OF HEALTH (NIH) STROKE SCALE SCORE WORSENED. A REPEAT CT REVEALED A NEW INTRACEREBRAL HEMORRHAGE, PROMPTING ADMINISTRATION OF TRANEXAMIC ACID (TXA) AND WAS TRANSFERRED TO ANOTHER FACILITY ON (B)(6). UPON ARRIVAL, FIBRINOGEN LEVELS WERE 241, AND NO FURTHER TXA WAS GIVEN. BLOOD PRESSURE WAS MANAGED WITH NICARDIPINE, AND CLOPIDOGREL WAS STARTED. THE PATIENT REMAINED COMMUNICATIVE UNTIL RESPIRATORY FAILURE DEVELOPED ON (B)(6), REQUIRING INTUBATION ON (B)(6). DESPITE EFFORTS TO IMPROVE THEIR CONDITION, THEY FAILED SPONTANEOUS BREATHING TRIALS AND DECLINED A TRACHEOSTOMY. TERMINAL EXTUBATION WAS PERFORMED ON (B)(6), AND THE PATIENT PASSED AWAY SHORTLY AFTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS LEADING UP TO THIS EVENT.

  Patient problems: Bradycardia; Intracranial Hemorrhage; Respiratory Failure

  MAUDE report 23157552 ↗
• InjurySep 18, 2025Contamination; Device Contamination with Chemical or Other Material; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Contamination; Device Contamination with Chemical or Other Material; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEWIRE WAS ENTANGLED THROUGH THE SHEATH REQUIRING ADDITIONAL DEVICE, AND A FOREIGN MATTER WAS FOUND ON THE GUIDEWIRE. A 035/180/3MM (B/1) AMPLATZ SUPER STIFF GUIDEWIRE USED DURING PACEMAKER REPLACEMENT AND WAS INSERTED INTO A NON-BOSTON SCIENTIFIC (BSC) INTRODUCER SHEATH. HOWEVER, DURING INTRODUCTION, THE GUIDEWIRE WAS ENTANGLED WITHIN THE SUPERIOR VENA CAVA (SVC) AND A KNOT WAS FORMED. A NON-BSC INTRODUCER SHEATH WAS USED TO REMOVE THE GUIDEWIRE. AFTER REMOVAL, IT WAS FOUND THAT A WHITE FOREIGN MATERIAL WAS ENTANGLED AT THE TIP OF THE GUIDEWIRE. IT WAS UNKNOWN IF THE FOREIGN MATTER ORIGINATED FROM BIOLOGICAL MATERIAL OR FROM THE DEVICE ITSELF. ANOTHER AMPLATZ SUPER STIFF GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084250 ↗
• MalfunctionJan 27, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THE DEVICE ENTRAPMENT OCCURRED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE IN A PULMONARY VEIN ISOLATION PROCEDURE FOR A PAROXYSMAL ATRIAL FIBRILLATION CASE. THE PATIENT HAD TORTUOUS ANATOMY. DURING THE PROCEDURE, THE AMPLATZ EXCHANGE WIRE WAS LOADED INTO THE TORFLEX TRANSSEPTAL GUIDING SHEATH.AFTER LOADING, IT WAS NOTED THAT THE WIRE BECAME LOOPED IN THE SMALL, FLUSH HOLE AT THE TIP OF THE SHEATH AND BECAME STUCK. ATTEMPTS WERE MADE TO MANIPULATE THE WIRE OUT OF THE SHEATH BUT WERE UNSUCCESSFUL. RESISTANCE WAS NOTED WHEN TRYING TO REMOVE THE WIRE. HENCE, THE PHYSICIAN REMOVED THE ENTIRE ASSEMBLY FROM LEFT ATRIUM WITH THE HELP OF A FLUORO IMAGING AND USED A VERSACROSS DEVICE TO REGAIN THE TRANSSEPTAL ACCESS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21248875 ↗
• MalfunctionMay 17, 2024Entrapment of Device; Difficult to Remove; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Difficult to Remove; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A 035/180/3MM (B/1) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE DURING A LEADLESS PACEMAKER IMPLANT. DURING THE PROCEDURE, THE DEVICE GOT STUCK AND WAS REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19344517 ↗
• MalfunctionJul 3, 2023Fracture; Difficult to Advance; Fracture; Difficult to Advance

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN JUGULAR VEIN. DURING A TRANSJUGULAR LIVER BIOPSY, A 035/180/3MM AMPLATZ SUPER STIFF GUIDEWIRE WAS ADVANCED FOR USE. HOWEVER, DURING ADVANCING, RESISTANCE WAS FELT AND WHEN THE GUIDEWIRE WAS PULLED OUT OF THE SHEATH, THE GUIDEWIRE HAD FRACTURED/SHREDDED. THE DEVICE WAS SIMPLY REMOVED, 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 17252519 ↗
• MalfunctionDec 21, 2022Stretched; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14DEC2022. IT WAS REPORTED THAT THE SPRING TIP UNRAVELED. AN AMPLATZ-PI GUIDEWIRE WAS SELECTED FOR USE TO PERFORM A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC STENT SHUNT (TIPSS). DURING THE PROCEDURE, THE SPRING TIP UNRAVELED. A NEW AMPLATZ-PI GUIDEWIRE WAS SELECTED AND USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, ANALYSIS REVEALED THAT THE CORE WIRE HAD DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16030149 ↗
• MalfunctionDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE UPON ANALYSIS COMPLETED ON 01DEC2022. IT WAS REPORTED THAT THE SPRING TIP UNRAVELED. AN AMPLATZ-PI GUIDEWIRE WAS SELECTED FOR USE TO PERFORM A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC STENT SHUNT (TIPSS). DURING THE PROCEDURE, THE SPRING TIP UNRAVELED. A NEW AMPLATZ-PI GUIDEWIRE WAS SELECTED AND USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, ANALYSIS REVEALED THAT THE CORE WIRE HAD DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992205 ↗
• MalfunctionDec 9, 2022Detachment 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 THE DISTAL TIP OF THE GUIDEWIRE BROKE. AN AMPLATZ PI GUIDEWIRE WAS SELECTED FOR USE IN A RADIOLOGY PROCEDURE. DURING THE PROCEDURE, THE DISTAL TIP BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15953835 ↗
• DeathDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEATH OCCURRED. A LIVE BROADCAST OF A HIGH RISK PERCUTANEOUS CORONARY INTERVENTION, WITH A CULOTTE TECHNIQUE APPROACH, WAS PERFORMED ON A BIFURCATED LESION LOCATED IN THE LEFT MAIN, LEFT CIRCUMFLEX, AND OSTIAL MARGINAL ARTERY. THE PATIENT WAS NOTED TO HAVE PRESENTED TO THE CASE IN POOR CONDITION, WITH A HISTORY OF DIABETES. 035/180/3MM AMPLATZ GUIDEWIRE, 2.00MM X 15MM EMERGE BALLOON, TWO 2.50MM X 15MM EMERGE BALLOONS, 4.00MM X 12MM EMERGE BALLOON, 2.25MM X 12MM EMERGE BALLOON, 4.00MM X 6MM EMERGE BALLOON, 2.25 X 16 SYNERGY STENT, 3.00 X 16 SYNERGY STENT, 2.25 X 28 SYNERGY STENT, 2.00 MM X 20.00 MM AGENT DCB, AND OPTICROSS HD VASCULAR IMAGING WERE USED TO TREAT THE PATIENT. IT WAS NOTED THAT THE STENTS WERE DEPLOYED AND NO ISSUES WITH ANY OF THE DEVICES OCCURRED. FOLLOWING TREATMENT WITH THE DEVICES, THE PATIENT'S CONDITION DESCENDING RAPIDLY DUE TO THE INTERVENTION, BUT WAS NOTED TO NOT BE CONSIDERED DEVICE RELATED. THE PATIENT WENT INTO PULMONARY EDEMA, WAS INTUBATED, AND THEN ULTIMATELY PASSED AWAY. IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED WITH ISCHEMIA. A LEFT FEMORAL APPROACH WAS USED ON THE TARGET LESION. THE CIRCUMFLEX AND INTERMEDIATE A

  Patient problems: Bradycardia; Ischemia; Myocardial Infarction; Pulmonary Edema; Tachycardia

  MAUDE report 12927454 ↗
• InjurySep 18, 2020Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDE WIRE TIP DETACHMENT AND THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE COMMON FEMORAL ARTERY (CFA). A 035/180/3MM (B/1) AMPLATZ GUIDE WIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, IT WAS NOTED THAT THE J TIP WAS DETACHED FROM THE CORE OF THE WIRE AND THE WIRE UNRAVELED, AND CAUSED FLOW LIMITING CLOT IN THE CFA. THE TIP HAD TO SNARE OUT AND DO A THROMBECTOMY WITH A TPA BOLUS AND BALLOON ANGIOPLASTY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE INTENDED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE OTHER LEG WAS DISCONTINUED.

  Patient problems: Thrombosis

  MAUDE report 10553288 ↗
• MalfunctionFeb 12, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24-JAN-2020. IT WAS REPORTED THAT GUIDEWIRE RESISTANCE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT SUBCLAVIAN VEIN. A 035/180/3MM AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. AFTER FLUSHING THE WIRE INSIDE IT'S SHEATH THE WIRE WAS DIFFICULT TO WITHDRAW. A 14X6CM XXL BALLOON CATHETER WAS ADVANCED BUT THE WIRE GOT STUCK INSIDE IT, AND SO IT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED COATING PEELED/SHEARED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9699201 ↗