HI-TORQUE SUPRA CORE 1002703-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648033001), received between Sep 22, 2017 and Sep 24, 2026 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (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 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 5, 2021Break; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Break; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE LEFT COMMON ILIAC ARTERY. THE HT SUPRA CORE .035 GUIDE WIRE WAS ADVANCED WITHOUT ISSUE; HOWEVER, DURING REMOVAL RESISTANCE WAS FELT WITH THE ANATOMY. THE GUIDE WIRE WAS PULLED HARDER AND THE WIRE CAME OUT. ONCE OUTSIDE THE PATIENT IT WAS NOTED THAT THE GUIDE WIRE WAS UNRAVELED AT THE TIP, THE COILS DETACHED BUT REMAINED ON THE WIRE. NOTHING REMAINED IN THE PATIENT. AN UNSPECIFIED 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 Consequences Or Impact To Patient

  MAUDE report 11117301 ↗
• MalfunctionSep 30, 2020Break; Stretched; Difficult to Advance; Break; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH NO CALCIFICATION, NO TORTUOSITY, AND 50% STENOSIS IN THE EXTERNAL ILIAC ARTERY. THE MIDDLE OF A .035 HT SUPRA CORE GUIDE WIRE FELT LIKE IT UNCOILED [UNRAVELED] AND A 5 FR CATHETER WAS NOT ABLE TO RE-ADVANCE OVER THE GUIDE WIRE. THEREFORE, A WIRE CUTTER WAS USED TO CUT THE GUIDE WIRE DISTAL TO THE ISSUE BECAUSE THE CATHETER COULD NOT BE ADVANCED OVER THE DAMAGED SECTION OF THE GUIDE WIRE AND THEN A NEW WIRE COULD BE EXCHANGED INSIDE THE CATHETER WITHOUT LOSING WIRE POSITION ACROSS THE LESION. ANOTHER SUPRA CORE GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10607881 ↗
• MalfunctionMay 7, 2020Peeled/Delaminated; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Peeled/Delaminated; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2020, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), MODERATELY CALCIFIED LESION. A SUPRACORE GUIDE WIRE WAS PLACED AND A COOK 0.035 CXI CATHETER ADVANCED OVER THE WIRE WITH RESISTANCE. AN ARMADA 35 BALLOON CATHETER WAS UNABLE TO ADVANCE OVER A SUPRACORE GUIDEWIRE. THE ARMADA WAS REMOVED WITHOUT REPORTED ISSUES. THE SUPRACORE GUIDE WIRE WAS THEN REMOVED THROUGH THE COOK CATHETER, WHEN APPROXIMATELY 100 CENTIMETERS FROM THE DISTAL TIP COILS WERE BENT AND THE WIRE IS OBSERVED WITH NO COATING. DIFFICULTY REMOVING THE WIRE WAS NOTED DUE TO THE BENT COILS. THE GUIDE WIRE TIP APPEARED UNDAMAGED. ANOTHER WIRE WAS USED IN REPLACEMENT. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10035709 ↗
• InjuryJan 3, 2020Product 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 AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) IN THE ABDOMINAL AORTA. THE SUPRACORE GUIDE WIRE WAS USED IN THE PROCEDURE AND DURING REMOVAL OF A BALLOON DILATATION CATHETER, SOME RESISTANCE WAS NOTED WITH THE GUIDE WIRE AS THERE WAS A ROUGH SPOT. WHEN REMOVED FROM THE ANATOMY, IT WAS NOTED THAT THERE WAS A PORTION OF THE WIRE WITH MISSING TEFLON. IT WAS ALSO NOTED THAT THIS PORTION OF EXPOSED WIRE APPEARED TO HAVE A BUMP OR NOTCH. THE PHYSICIAN DOES NOT BELIEVE THAT ANY PORTION REMAINED IN THE PATIENT AND NO INTERVENTION WAS PERFORMED TO REMOVE ANYTHING. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS; HOWEVER, AS THE PORTION IS MISSING AND CANNOT BE SEEN UNDER FLUOROSCOPY IT IS POSSIBLE IT REMAINED IN THE PATIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9548859 ↗
• MalfunctionDec 23, 2019Difficult to Remove; Defective Device; Difficult to Advance; Difficult to Remove; Defective Device; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PATIENT WITH A TYPE III ARCH, HIGH-GRADE 80-85% DISSECTED RIGHT COMMON INTERNAL CAROTID ARTERY. REPORTEDLY, THE WELD ON THE SUPRACORE WAS TOO LARGE AND BECAME STUCK IN THE 5FR NON-ABBOTT GUIDING CATHETER DURING ADVANCEMENT. THE DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED AS EXPECTED WITH A NEW SUPRACORE GUIDE WIRE AND ANOTHER NON-ABBOTT GUIDING CATHETER. THERE WERE NO REPORTED 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 9512216 ↗
• InjuryMay 20, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE AORTA ARTERY. A HI-TORQUE SUPRA CORE GUIDE WIRE WAS ADVANCED AND A PROSTAR WAS ADVANCED OVER THE GUIDE WIRE. THE GUIDE WIRE WAS BACKED UP AND THE SUTURES WERE PLACED USING A PRE-CLOSE TECHNIQUE. THE GUIDE WIRE WAS RE-ADVANCED AND DURING REMOVAL OF THE PROSTAR DEVICE RESISTANCE WITH THE GUIDE WIRE WAS FELT. THE PROCEDURE WAS PERFORMED AND THE PROSTAR SUTURES WERE USED SUCCESSFULLY TO CLOSE THE ACCESS SITE. A FEMORAL ANGIOGRAM WAS PERFORMED AND IT WAS NOTED THAT THE GUIDE WIRE HAD SEPARATED AND THE TIP WAS 3CM FROM THE ACCESS SITE. A CUT-DOWN WAS PERFORMED TO REMOVE THE SEPARATED GUIDE WIRE TIP AND THE PATIENT IS FINE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8626085 ↗
• MalfunctionSep 22, 2017Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE 100% TOTAL OCCLUSION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A SUPRA CORE GUIDE WIRE WAS ADVANCED ACROSS THE LESION AND THE LESION WAS BALLOONED WITH A NON-ABBOTT BALLOON DILATATION CATHETER (BDC). THE BDC WAS REMOVED AND A DRUG ELUTING BALLOON (DEB) WAS ADVANCED OVER THE SUPRA CORE GUIDE WIRE BUT THE DEB WAS UNABLE TO CROSS THE TRANSITION OF THE WIRE. A SEPARATION WAS NOTED AT THE TRANSITION ON THE SUPRA CORE GUIDE WIRE. THE DEB WAS REMOVED FROM THE SUPRA CORE AND A CXI CATHETER WAS ADVANCED OVER THE SUPRA CORE GUIDE WIRE. THE SUPRA CORE WAS THEN REMOVED AND A NEW SUPRA CORE WAS ADVANCED. THREE NEW DEBS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO INTERVENTION TO REMOVE THE SUPRA CORE GUIDE WIRE. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6888937 ↗