HI-TORQUE SUPRA CORERecalls & reported problems across all models

We found 2 models of HI-TORQUE SUPRA CORE by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2016 and Sep 24, 2026 — classified as 2 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported HI-TORQUE SUPRA CORE problems

HI-TORQUE SUPRA CORE models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HI-TORQUE SUPRA CORE 1002703-01

  WIRE, GUIDE, CATHETER
  15 reports
• HI-TORQUE SUPRA CORE 1002703-02

  WIRE, GUIDE, CATHETER
  15 reports

Recent HI-TORQUE SUPRA CORE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Separation

  It was reported that prior to use the SupraCore guide wire broke. There was no patient involvement. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881373 ↗
• 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 ↗
• MalfunctionApr 1, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. AFTER PRE-DILATATION, THE HT SUPRA CORE 35 GUIDE WIRE (GW) WAS ADVANCE TO THE TARGET LESION AND THEN A NON-ABBOTT STENT WAS ADVANCED ON THE GW WITH RESISTANCE. THE STENT WAS NOTED TO PARTIALLY DEPLOY, PRIOR TO ENTERING THE SHEATH AND A BURR [BREAK] WAS NOTED TO BE ON THE GW RIBBON COIL. THE STENT AND GW WERE REMOVED. A NON-ABBOTT GW AND AN UNSPECIFIED STENT WERE USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. OUTSIDE THE PATIENT THE PHYSICIAN MANIPULATED THE BURR AND A PIECE OF THE RIBBON COIL CAME OFF ON THE PHYSICIAN'S GLOVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748685 ↗
• MalfunctionFeb 11, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED DURING THE PROCEDURAL PREPARATION OF A 300CM HT SUPRA CORE GUIDEWIRE (GW), THAT THE COVERING [COATING] ON THE GW WAS NOTED TO BE INCOMPLETE, WHEN THE DEVICE WAS REMOVED FROM ITS PACKAGE. THEREFORE, A NEW SUPRA CORE GW WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INVOLVEMENT NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21357958 ↗
• MalfunctionDec 27, 2023Break; Difficult to Remove; Stretched; Difficult to Advance; Break; Difficult to Remove; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE SUPRA CORE GUIDE WIRE (GW) WAS ADVANCING TO THE TARGET LESION; HOWEVER, RESISTANCE WAS NOTED WITH THE GUIDE CATHETER AS THE GUIDE CATHETER WAS NOTED TO BECOME KINKED. THEREFORE, THE GW WAS REMOVED THE PATIENT AND RESISTANCE WAS NOTED ALSO DURING REMOVAL WITH THE GUIDE CATHETER. THE GW BROKE AND THE COILS BECAME UNRAVELED; HOWEVER REMAINED IN ONE PIECE. THE PROCEDURE WAS CONTINUED WITH A NON-ABBOTT GW. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18406414 ↗
• MalfunctionDec 11, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). RIGHT FEMORAL ACCESS ACCESS WAS USED TO ATTEMPT TO ADVANCE THE SUPRACORE GUIDEWIRE (GW) TO THE TARGET LESION; HOWEVER, RESISTANCE WAS NOTED WITH THE GUIDE CATHETER (GC). THEREFORE, THE GW WAS REMOVED AND RESISTANCE WAS ALSO NOTED AND THE GW BECAME STUCK WITH THE GC. THE GUIDEWIRE AND GUIDE CATHETER HAD TO BE REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER SUPRA CORE GUIDEWIRE WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301829 ↗
• 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 ↗
• MalfunctionNov 30, 2022Break; Break

  IT WAS REPORTED THAT THE SUPRACORE GUIDE WIRE WAS OPENED UNDER STERILE CONDITIONS AND INSPECTED. THE COILS OF THE WIRE WERE SEPARATED BUT THE CORE WAS INTACT. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW SUPRACORE GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887627 ↗
• MalfunctionDec 16, 2021Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION IN THE FEMORAL ARTERY. A .035 H-T SUPRA CORE GUIDE WIRE (GW) WAS ADVANCED TOWARDS THE LESION WITH RESISTANCE MET FROM THE ANATOMY AND COULD NOT REACH THE TARGET SITE. THE GUIDE WIRE WAS REMOVED, AND IT WAS NOTICED THAT THE TIP COILS OF THE GUIDE WIRE HAD BECOME UNRAVELED. ANOTHER SAME SIZE GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13020412 ↗
• 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 29, 2021Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT LOWER EXTREMITIES. A H-T SUPRA CORE 35 GUIDE WIRE WAS NOTED TO UNRAVEL AT THE JOINT DURING USE. THE WIRE WAS NOT SEPARATED COMPLETELY ONLY AT THE COILS AND STRETCHED. THE DEVICE WAS REMOVED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085209 ↗

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