HI-TORQUE VERSACORERecalls & reported problems across all models

We found 7 models of HI-TORQUE VERSACORE by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Mar 23, 2018 and Jul 17, 2024 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (16 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 VERSACORE problems

HI-TORQUE VERSACORE models

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

• HI-TORQUE VERSACORE 1012068-09

  WIRE, GUIDE, CATHETER
  16 reports
• HI-TORQUE VERSACORE 1012068-06

  WIRE, GUIDE, CATHETER
  3 reports
• HI-TORQUE VERSACORE 1012068-07

  WIRE, GUIDE, CATHETER
  3 reports
• HI-TORQUE VERSACORE 1012068-08

  WIRE, GUIDE, CATHETER
  3 reports
• HI-TORQUE VERSACORE 1012068-01

  WIRE, GUIDE, CATHETER
  2 reports
• HI-TORQUE VERSACORE 1012068-02

  WIRE, GUIDE, CATHETER
  1 report
• HI-TORQUE VERSACORE 1012068-05

  WIRE, GUIDE, CATHETER
  1 report

Recent HI-TORQUE VERSACORE adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJul 8, 2024Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE LEFT EXTERNAL ILLIAC ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 7X80MM ABSOLUTE PRO SELF EXPANDING STENT WAS ADVANCED OVER A 0.035 HI-TORQUE VERSACORE FLOPPY GUIDE WIRE WITHOUT RESISTANCE. THE THUMBWHEEL WAS ENGAGED AND THE STENT DEPLOYED WITHOUT ISSUES. UPON WITHDRAWAL, RESISTANCE WAS FELT WITH THE GUIDE WIRE. SALINE WAS FLUSHED THROUGH THE ABSOLUTE PRO DELIVERY SYSTEM USING THE HYDROPLANE TECHNIQUE, IN ORDER TO SLIDE THE ABSOLUTE PRO DELIVERY SYSTEM OFF THE GUIDE WIRE. THE GUIDE WIRE WAS REMOVED AND PROXIMAL PORTION OF THE WIRE WAS NOTED TO BE BENT YET REMAINED INTACT. 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 19690704 ↗
• 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 ↗
• MalfunctionSep 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF THE HI-TORQUE (HT) VERSACORE GUIDE WIRE, THE TIP SEPARATED. ANOTHER SAME SIZE HT VERSCORE GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422483 ↗
• 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 ↗
• MalfunctionAug 28, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MESENTERIC ARTERY. THE VERSACORE GUIDE WIRE COULD NOT BE REMOVED FROM AN UNSPECIFIED BALLOON CATHETER. THE DEVICES WERE REMOVED AS A SINGLE UNIT. AN UNSPECIFIED GUIDE WIRE AND NEW BALLOON CATHETER WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10466891 ↗
• MalfunctionAug 27, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED AS A GENERAL COMMENT THAT VERSACORE GUIDE WIRES ARE DIFFICULT TO REMOVE FROM THE BALLOON CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10463661 ↗
• MalfunctionMar 25, 2020Break; Break

  IT WAS REPORTED THAT DURING PREPARATION OF THE HI-TORQUE VERSACORE GUIDE WIRE, THE COIL SEPARATED FROM THE WHITE PART OF THE GUIDE WIRE, THE COILS DID NOT UNRAVEL. IT WAS STATED THAT GUIDE WIRE DID NOT SEPARATE INTO TWO PIECES. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9880126 ↗
• MalfunctionAug 22, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A HT VERSACORE FLOPPY GUIDE WIRE WAS UNWOUND AND IT SEPARATED INTO TWO PIECES. THE GUIDE WIRE WAS NOT USED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8922278 ↗

Other Abbott Vascular Inc. products

• MITRACLIP8 models · 5,973 reports · 2 recalls
• NC TREK56 models · 1,842 reports · 12 recalls
• Armada213 models · 1,904 reports
• Indeflator7 models · 1,196 reports · 9 recalls
• XIENCE Sierra56 models · 1,161 reports · 1 recall
• XIENCE Skypoint69 models · 1,142 reports
• Graftmaster15 models · 1,071 reports
• TREK50 models · 909 reports