HI-TORQUE SUPRA CORE 1002703-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648032998), received between Dec 1, 2016 and Sep 26, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN THE H-T SUPRA CORE.035 190CM GUIDE WIRE (GW) WAS REMOVED FROM THE PACKAGING, THE COIL TIP AND CORE OF THE GW WAS NOTED TO BE BROKEN; HOWEVER, REMAINED IN ONE PIECE. THEREFORE, THE GW WAS NOT USED IN THE PROCEDURE. ANOTHER SUPRA CORE GW WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23158865 ↗
• MalfunctionSep 17, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT DIAGNOSIS WAS TO BE PERFORMED ON A RIGHT CORONARY ARTERY THAT IS 75% STENOSED. DURING THE EXCHANGE OF A 6F FR4 DIAGNOSTIC CATHETER TO A 6F JR3.5 GUIDE CATHETER, RESISTANCE WAS NOTED AND THE TIP COILS OF A 190CM 0.035" HI-TORQUE SUPRA CORE GUIDEWIRE WERE SEPARATED/UNRAVELED, HOWEVER THE CORE INTACT. A BMW GUIDEWIRE WAS USED TO COMPLETE THE DIAGNOSTIC PORTION OF THE CASE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080056 ↗
• MalfunctionJan 12, 2023Material Separation; Stretched; Material Separation; Stretched

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A SUPERFICIAL FEMORAL ARTERY GRAFT WITH NO CALCIFICATION. THE SUPRA CORE GUIDE WIRE WAS SUCCESSFULLY ADVANCED AND REMOVED WITHOUT RESISTANCE. AFTER REMOVAL, IT WAS NOTED THAT THE GUIDE WIRE TIP WAS STRETCHED. THERE WAS NO SEPARATION NOTED. THE GUIDE WIRE WAS REPLACED WITH A NEW GUIDE WIRE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THE CORE WAS BENT, KINKED THEN SEPARATED 5MM PROXIMAL TO THE TIP BALL. THE CORE MATERIAL AT THE SEPARATION WAS JAGGED. THE ACCOUNT CONFIRMED THE SEPARATION OCCURRED DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16151358 ↗
• MalfunctionSep 28, 2021Product Quality Problem; Material Split, Cut or Torn; Product Quality Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT COMMON ILIAC ARTERY. A HI TORQUE SUPRACORE GUIDE WIRE WAS BEING ADVANCED WITH AN UNSPECIFIED CATHETER WHEN A BUMP AND MISSING COATING ON A PORTION OF THE GUIDE WIRE THAT IS OUTSIDE THE PATIENT ANATOMY WAS NOTED. ANOTHER SUPRACORE GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541657 ↗
• MalfunctionSep 28, 2021Product Quality Problem; Difficult to Remove; Material Split, Cut or Torn; Product Quality Problem; Difficult to Remove; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS LEFT COMMON ILIAC ARTERY. A HI TORQUE SUPRACORE GUIDE WIRE WAS USED WITH AN UNSPECIFIED BALLOON, AND THE DEVICES FACED RESISTANCE DURING REMOVAL. THEN, A BUMP AND MISSING COATING ON A PORTION OF THE GUIDE WIRE THAT IS OUTSIDE THE PATIENT ANATOMY WAS NOTED. ANOTHER SUPRACORE GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541556 ↗
• MalfunctionAug 19, 2021Break; Product Quality Problem; Stretched; Break; Product Quality Problem; Stretched

  IT WAS REPORTED THAT POSSIBLY WHEN REMOVING THE DEVICE FROM THE PROTECTIVE PACKAGING, OR WHEN GETTING READY TO INSERT, OR WHEN INSERTING THE SUPRA CORE GUIDE WIRE INTO THE SHEATH, THE SURFACE FELT IRREGULAR AND EITHER DURING REMOVAL FROM THE PROTECTIVE PACKAGING OR SHEATH, IT WAS NOTED THAT THE COILS WERE STRETCHED. THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NOT ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. ANOTHER SUPRACORE GUIDE WIRE WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS REVEALED THE RIBBON COILS WERE UNRAVELED, STRETCHED AND SEPARATED (NOT IN TWO SEPARATE PIECES) DISTAL TO THE PROXIMAL SOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12345528 ↗
• MalfunctionJul 20, 2021Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED EXTERNAL ILIAC ARTERY THAT WAS OCCLUDED. A NON-ABBOTT 4F GUIDE CATHETER WAS INSERTED VIA THE RIGHT COMMON FEMORAL ARTERY ACCESS SITE. WHEN INSERTING THE SUPRACORE 35 GUIDE WIRE (GW) THERE WAS RESISTANCE MET WITH THE NON-ABBOTT 4F GUIDE CATHETER. IT FELT LIKE THE CATHETER CLAMPED ON THE GUIDEWIRE. THEREFORE THE GUIDE CATHETER WAS ATTEMPTED TO BE RETRACTED; HOWEVER, IT MET RESISTANCE WITH THE GW AND THE GUIDE CATHETER TIP (APPROXIMATELY 10CM) CAME OFF AND REMAINED ON THE SUPRACORE GW. THE GW WAS NOTED IN A STABLE POSITION, SO IT WAS DECIDED TO REMOVE THE REST OF THE GUIDE CATHETER AND SEND THE PATIENT TO SURGERY TO RETRIEVE THE GUIDE CATHETER TIP. THE SUPRACORE GW WAS ADVANCED FROM THE LEFT INTO THE RIGHT SUPERFICIAL FEMORAL ARTERY GROIN, WHEN A NON-ABBOTT CATHETER WAS THEN PUSHED OVER THE SUPRACORE GW FROM THE LEFT AND THE TORN TIP WAS ADVANCED OVER THE WIRE TO THE RIGHT GROIN, WHERE THE TIP WAS THEN SIMPLY REMOVED FROM THE GW. CONTINUATION OF THE PROCEDURE WITH DILATION OF THE OCCLUSION AND INSERTION OF AN ABSOLUTE STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196842 ↗
• MalfunctionJun 15, 2021Break; Break

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE CAROTID ARTERY. THE SUPRACORE GUIDE WIRE WAS ADVANCED TO THE LESION WITHOUT ISSUE. WHEN REMOVING THE INTERVENTIONAL SHEATH, IT WAS NOTED THE DISTAL PORTION OF THE GUIDE WIRE WAS UNRAVELED. THE GUIDE WIRE WAS REMOVED WITHOUT RESISTANCE AND REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005747 ↗
• MalfunctionSep 14, 2020Break; Difficult to Remove; Deformation Due to Compressive Stress; Break; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED DE NOVO COMMON ILIAC ARTERY. WHILE REMOVING THE SUPRACORE GUIDE WIRE OUT OF THE INTRODUCER SHEATH THE TIP BECAME KINKED AND FRACTURED. RESISTANCE WAS NOTED WITH THE SHEATH DURING REMOVAL. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10532178 ↗
• MalfunctionJun 3, 2020Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH NO CALCIFICATION IN THE SUPERFICIAL FEMORAL ARTERY. THE SUPRACORE GUIDE WIRE WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. DURING THE PROCEDURE, THE PHYSICIAN DECIDED TO CHANGE GUIDE WIRES; HOWEVER, WHEN THE GUIDE WIRE WAS WITHDRAWN THE COILS BECAME STRETCHED AND UNRAVELED. THERE WAS NO RESISTANCE NOTED. THE GUIDE WIRE WAS REMOVED IN ONE PIECE, THERE WAS NO SEPARATION NOTED. A NEW GUIDE WIRE WAS ADVANCED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10115229 ↗
• MalfunctionJun 1, 2020Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN AORTIC ANEURYSM. THE SUPRACORE GUIDE WIRE WAS USED TO DEPLOY A PROGLIDE USING A PRE-CLOSE TECHNIQUE THEN EXCHANGED FOR A 12F NON-ABBOTT SHEATH TO PERFORM AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) USING AN ILIAC BRANCH ENDOPROSTHESIS (IBE). WHEN REMOVING THE SUPRACORE, IT WAS NOTICED THERE WAS STRETCHING OF THE COILS ON THE FLOPPY TIP AND A POSSIBLE BREAK. IT WAS CONFIRMED THAT THE WIRE WAS NOT SEPARATED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10105774 ↗
• MalfunctionSep 4, 2019Peeled/Delaminated; Difficult to Advance; Material Deformation; Peeled/Delaminated; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY. A HI-TORQUE SUPRA CORE 35 GUIDE WIRE WAS ADVANCED WITHOUT RESISTANCE; HOWEVER, THE COILS BUNCHED UP WHICH RESULTED IN AN INCREASE IN DIAMETER AT THE PROXIMAL END OUTSIDE THE PATIENT ANATOMY. THE PHYSICIAN DIDN¿T WANT TO LOSE VESSEL ACCESS AND BUNCHING OF THE COILS DID NOT ALLOW A 6F SHEATH TO ADVANCE OVER THE GUIDE WIRE; THEREFORE, THE GUIDE WIRE WAS CUT TO ADVANCE THE 6F SHEATH. THE 6F SHEATH WAS ABLE TO BE SUCCESSFULLY USED. ACCESS WAS MAINTAINED IN ORDER TO USE A CLOSURE DEVICE, BUT THE CASE WAS ABANDONED POST CLOSURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENTLY, THE RETURN DEVICE ANALYSIS IDENTIFIED THAT THE TEFLON ON THE PROXIMAL RIBBON COIL AT THE SEPARATION WAS SCRATCHED AND PEELING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8963053 ↗
• MalfunctionAug 26, 2019Flaked; Product Quality Problem; Difficult to Advance; Flaked; Product Quality Problem; Difficult to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE, A NON-ABBOTT 6F SHEATH WAS UNABLE TO BE ADVANCED OVER A HI TORQUE SUPRA CORE 35 GUIDE WIRE DUE TO A ROUGH AREA ON THE CORE TOWARDS THE TIP OF THE WIRE. A NEW SURPACORE GUIDE WIRE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED GOODS ANALYSIS IDENTIFIED THAT THERE WERE THREE PIECES OF DETACHED TEFLON COATING NOTED ON THE PROXIMAL SOLDER JOINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8932483 ↗
• MalfunctionMar 16, 2019Product Quality Problem; Material Separation; Product Quality Problem; Material Separation

  IT WAS REPORTED THAT DURING AN ILIAC ARTERY INTERVENTION, WHILE ADVANCING THE 300 CM HI-TORQUE SUPRA CORE GUIDE WIRE THROUGH THE SHEATH, A SHARP SECTION ON THE COILS OF THE WIRE OUTSIDE OF THE ANATOMY, WAS NOTED. THE WIRE WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER 300 CM SUPRA CORE WAS USED TO COMPLETE THE ILIAC INTERVENTION. DEVICE ANALYSIS REVEALED THAT THE RIBBON COILS WERE DETACHED FROM THE PROXIMAL SOLDER JOINT AND WERE UNRAVELED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8426807 ↗
• MalfunctionDec 1, 2016Detachment Of Device Component; Difficult To Position; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A HI-TORQUE SUPRA CORE GUIDE WIRE WAS INSERTED INTO A 6F SHEATH WITH NO COMPLICATIONS. THE 6F SHEATH WAS REMOVED AND A DILATOR WAS ADVANCED WHEN RESISTANCE WAS FELT WITH THE GUIDE WIRE. THE DILATOR AND GUIDE WIRE WERE BEING REMOVED WHEN RESISTANCE WAS FELT. AFTER REMOVAL IT WAS NOTICED THAT THE GUIDE WIRE WAS FRAYED. THE FRAYED PART WAS REMOVED AND THE GUIDE WIRE WAS RE-INSERTED INTO A NON-ABBOTT DEVICE; HOWEVER, IT COULD NOT ADVANCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW HI-TORQUE SUPRA CORE GUIDE WIRE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS CONFIRMED THAT THE GUIDE WIRE WAS SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6139462 ↗