HI-TORQUE VERSACORE 1012068-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648124235), received between Mar 23, 2018 and Jul 17, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2024Break; Break

  IT WAS REPORTED THAT PRIOR TO USE WHEN REMOVING THE 260CM HT VERSACORE GUIDE WIRE FROM THE DISPENSER HOOP WITH NO RESISTANCE, THE GREEN/WHITE TRANSITION AREA OF THE WIRE BECAME SEPARATED, BUT NOT CONFIRMED IN TWO PIECES. ANOTHER VERSACORE GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763940 ↗
• MalfunctionMay 6, 2024Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE LEFT HEART. DURING ADVANCEMENT OF THE VERSACORE GUIDE WIRE THERE WAS RESISTANCE WITH THE CATHETER AND THE TIP COILS SEPARATED. RESISTANCE WAS NOTED DURING REMOVAL OF THE GUIDE WIRE FROM THE CATHETER HOWEVER IT WAS ABLE TO BE REMOVED IN ONE PIECE WITHOUT MEDICAL INTERVENTION. A NEW GUIDE WIRE WAS USED TO CONTINUE 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 19254315 ↗
• MalfunctionJan 10, 2024Material Separation; Defective Device; Material Separation; Defective Device

  IT WAS REPORTED THAT WHEN THE HT VERSACORE MOD J 260CM GUIDEWIRE WAS BEING INSERTING INTO THE PATIENT VIA THE SHEATH. WHILE EXITING THE HOOP TRAY, IT WAS OBSERVED THAT THE DEVICE LOOKED A BIT SHORT. THE OVERALL LENGTH WAS 189 CM INSTEAD OF 260 CM; THEREFORE, THE DECISION WAS MADE TO NOT CONTINUE TO USE THE DEVICE. THE GUIDE WIRE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN DEVICE ANALYSIS FOUND THAT THE THREADED EXTENSION WAS SEPARATED FROM THE CORE WIRE 77 CENTIMETERS PROXIMAL FROM THE PROXIMAL END OF THE TEFLON COATED CORE, EXPOSING THE CORE WIRE FOR A LENGTH OF 1.5 MILLIMETERS (MM). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18488867 ↗
• MalfunctionApr 3, 2023Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). A 260CM HT VERSACORE MOD J GUIDE WIRE (GW) WAS ADVANCED TO THE DESIRED LOCATION AND USED WITHOUT ISSUE. AFTER REMOVAL, IT WAS NOTED THAT THE GUIDE WIRE BROKE, BUT REMAINED IN ONE PIECE AND THE COATING WAS NOTED TO BE PULLED AWAY FROM THE WIRE, BUT REMAINED IN ONE PIECE, AT THE WIRE BREAK. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. AN UNSPECIFIED WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16669695 ↗
• MalfunctionMar 24, 2023Break; Break

  USER FACILITY MEDWATCH REPORT RECEIVED ON 5/9/2023, STATES: "DESCRIBE THE EVENT OR PROBLEM: A VERSACORE WIRE WAS USED TO EXCHANGE CATHETERS. THE WIRE CONSISTS OF TWO DIFFERENT TYPES OF MATERIAL. THE JUNCTION THAT HOLDS THEM TOGETHER STARTED TO SEPARATE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : LEFT HEART CATH. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16612263 ↗
• MalfunctionJan 20, 2023Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, 65% STENOSED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AN HT VERSACORE MOD J 260CM GUIDE WIRE (GW) WAS FLUSHED IN THE HOOP TRAY WITHOUT ISSUE. UPON ADVANCING A NON-ABBOTT TERUMO SHEATH, RESISTANCE WAS MET WITH THE GW AND THE SHEATH, AND THE GW WAS REMOVED. IT WAS NOTED THAT THERE WAS A GAP IN THE GW COILS HOWEVER THE GW REMAINED IN ONE PIECE. A SECOND HT VERSACORE MOD J 260CM GW WAS FLUSHED IN THE HOOP TRAY WITHOUT ISSUE, HOWEVER UPON ADVANCING INTO THE PATIENT ANATOMY, THE PHYSICIAN NOTICED THE SAME ISSUE WITH THIS GW, THERE WAS A GAP IN THE COILS BUT IT REMAINED IN ONE PIECE. THERE WAS NO REPORTED RESISTANCE ADVANCING THE SECOND GW. THE GW WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A 3RD, NON-ABBOTT GW WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218854 ↗
• MalfunctionJan 20, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, 65% STENOSED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AN HT VERSACORE MOD J 260CM GUIDE WIRE (GW) WAS FLUSHED IN THE HOOP TRAY WITHOUT ISSUE. UPON ADVANCING A NON-ABBOTT TERUMO SHEATH, RESISTANCE WAS MET WITH THE GW AND THE SHEATH, AND THE GW WAS REMOVED. IT WAS NOTED THAT THERE WAS A GAP IN THE GW COILS HOWEVER THE GW REMAINED IN ONE PIECE. A SECOND HT VERSACORE MOD J 260CM GW WAS FLUSHED IN THE HOOP TRAY WITHOUT ISSUE, HOWEVER UPON ADVANCING INTO THE PATIENT ANATOMY, THE PHYSICIAN NOTICED THE SAME ISSUE WITH THIS GW, THERE WAS A GAP IN THE COILS BUT IT REMAINED IN ONE PIECE. THERE WAS NO REPORTED RESISTANCE ADVANCING THE SECOND GW. THE GW WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A 3RD, NON-ABBOTT GW WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218850 ↗
• MalfunctionMay 4, 2022Product Quality Problem; Difficult to Remove; Difficult to Advance; Product Quality Problem; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE VERSACORE GUIDE WIRE WAS ADVANCED VIA CROSSOVER PROCEDURE, RIGHT TO LEFT, USING A 6FRENCH SHEATH. DURING ADVANCEMENT, SOME RESISTANCE WAS NOTED AND THE DEVICE FELT "FUNNY". THE DEVICE WAS ABLE TO ADVANCE THROUGH THE BIFURCATION, BUT AS THE DEVICE DIDN'T FEEL RIGHT, THE DECISION WAS MADE TO REMOVE IT. SOME RESISTANCE WAS NOTED DURING REMOVAL AND THE DEVICE WAS REMOVED INTACT. UPON REMOVAL, IT WAS NOTED THAT THE DISTAL TIP DID NOT FEEL SMOOTH, AT THE WELD POINT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274997 ↗
• MalfunctionApr 29, 2022Product Quality Problem; Difficult to Remove; Difficult to Advance; Product Quality Problem; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE VERSACORE GUIDE WIRE WAS ADVANCED VIA CROSSOVER PROCEDURE, RIGHT TO LEFT, USING A 6FRENCH SHEATH. DURING ADVANCEMENT, SOME RESISTANCE WAS NOTED AND THE DEVICE FELT "FUNNY". AS THE DEVICE DIDN'T FEEL RIGHT, THE DECISION WAS MADE TO REMOVE IT. SOME RESISTANCE WAS NOTED DURING REMOVAL AND THE DEVICE WAS REMOVED INTACT. UPON REMOVAL, IT WAS NOTED THAT THE DISTAL TIP DID NOT FEEL SMOOTH, AT THE WELD POINT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14255888 ↗
• MalfunctionNov 19, 2018Difficult to Remove; Stretched; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE ANTERIOR TIBIAL ARTERY. AFTER USE, THERE WAS RESISTANCE WHEN REMOVING THE HI-TORQUE VERSACORE GUIDE WIRE FROM THE ANATOMY AND IT FELT AS IF THE GUIDE WIRE HAD SEPARATED. ANOTHER GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8085742 ↗
• MalfunctionNov 2, 2018Material Separation; Failure to Advance; Difficult to Advance; Material Separation; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. A HT VERSACORE GUIDE WIRE WAS ADVANCED THROUGH A UNIVERSAL FLUSH CATHETER. AN ATTEMPT TO PUSH DOWN AND FURTHER ADVANCE THE GUIDE WIRE TO EXCHANGE THE SHEATH WAS MADE; HOWEVER, THE WIRE DID NOT ADVANCE. IT IS UNKNOWN IF THE RESISTANCE ADVANCING THE GUIDE WIRE WAS WITH THE ANATOMY OR THE UNIVERSAL FLUSH CATHETER. THE GUIDE WIRE WAS REMOVED WITHOUT RESISTANCE, BUT IT WAS NOTED THAT THE TIP SEPARATED. THE UNIVERSAL FLUSH CATHETER WAS REMOVED AND THE TIP OF THE GUIDE WIRE WAS INSIDE THE UNIVERSAL FLUSH CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW UNIVERSAL FLUSH CATHETER AND A NEW HT VERSACORE GUIDE WIRE. 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 8034324 ↗
• MalfunctionOct 28, 2018Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT TWO VERSACORE GUIDE WIRES WERE USED IN THE SAME PROCEDURE. RESISTANCE WAS FELT WITH THE ANATOMY DURING THE REMOVAL OF BOTH VERSACORE GUIDE WIRES, AND THE GUIDE WIRE TIPS FELT LIKE THEY WERE UNRAVELING. BOTH GUIDE WIRES WERE REMOVED FROM THE ANATOMY AS A SINGLE UNIT, AND THE WIRE SEPARATED INTO TWO PIECES OUTSIDE OF THE PATIENT ANATOMY. NO INTERVENTION WAS REQUIRED TO RETRIEVE THE SEPARATED PORTION. ANOTHER UNSPECIFIED GUIDE WIRE WAS USED TO 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 Consequences Or Impact To Patient

  MAUDE report 8011701 ↗
• MalfunctionOct 28, 2018Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT TWO VERSACORE GUIDE WIRES WERE USED IN THE SAME PROCEDURE. RESISTANCE WAS FELT WITH THE ANATOMY DURING THE REMOVAL OF BOTH VERSACORE GUIDE WIRES, AND THE GUIDE WIRE TIPS FELT LIKE THEY WERE UNRAVELING. BOTH GUIDE WIRES WERE REMOVED FROM THE ANATOMY AS A SINGLE UNIT, AND THE WIRE SEPARATED INTO TWO PIECES OUTSIDE OF THE PATIENT ANATOMY. NO INTERVENTION WAS REQUIRED TO RETRIEVE THE SEPARATED PORTION. ANOTHER UNSPECIFIED GUIDE WIRE WAS USED TO 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 Consequences Or Impact To Patient

  MAUDE report 8011685 ↗
• MalfunctionOct 23, 2018Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CAROTID ARTERY. THERE WAS RESISTANCE WITH THE ANATOMY WHILE WITHDRAWING THE VERSACORE GUIDE WIRE, AND THE COIL FELT LIKE IT WAS STRETCHING AND THAT THE TIP AND WIRE HAD DISCONNECTED. UPON REMOVAL FROM THE PATIENT ANATOMY, THE GUIDE WIRE TIP WAS NOTED TO BE SEPARATED, BUT WAS NOT IN TWO PIECES. THE GUIDE WIRE WAS FULLY RETRIEVED FROM THE PATIENT, AND ANOTHER UNSPECIFIED GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7997013 ↗
• MalfunctionSep 7, 2018Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE NON-ABBOTT PIGTAIL CATHETER WAS ADVANCED ON A HI-TORQUE (HT) VERSACORE GUIDE WIRE WITHOUT RESISTANCE. DURING GUIDE WIRE REMOVAL, THE GUIDE WIRE FELT RESISTANCE WITH THE CATHETER AND THE DEVICES BECAME STUCK AND WERE REMOVED FROM THE PATIENT ANATOMY AS A SINGLE UNIT. THE GUIDE WIRE WAS INSPECTED AFTER IT WAS REMOVED FROM THE PATIENT ANATOMY, AND THE GUIDE WIRE REMAINED IN ONE PIECE; HOWEVER, THE COIL WAS OBSERVED TO BE SEPARATED NEAR THE SOLDER JOINT, AND THE INNER CORE WAS HELD TOGETHER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER THE FIRST VERSACORE GUIDE WIRE WAS REMOVED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7857891 ↗
• MalfunctionMar 23, 2018Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT IT WAS FELT THE VERSACORE J MODIFIED GUIDE WIRE WAS STICKING ON THE IMPELLA DEVICE AND COULD NOT BE REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7368125 ↗