HI-TORQUE VERSATURNRecalls & reported problems across all models

We found 4 models of HI-TORQUE VERSATURN by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 151 adverse event reports in the FDA's MAUDE database, received between Oct 19, 2016 and Sep 17, 2026 — classified as 1 death, 46 injuries, 104 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (86 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 VERSATURN problems

HI-TORQUE VERSATURN models

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

• HI-TORQUE VERSATURN 1013317

  Wire, guide, catheter
  111 reports
• HI-TORQUE VERSATURN 1013319J

  Wire, guide, catheter
  1 death18 reports
• HI-TORQUE VERSATURN 1013319

  Wire, guide, catheter
  14 reports
• HI-TORQUE VERSATURN 1013317J

  Wire, guide, catheter
  8 reports

Recent HI-TORQUE VERSATURN adverse event reports

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

• InjurySep 17, 2026Difficult to Remove; Material Separation

  It was reported that the HT Versaturn guidewire was used in a 100% in-stent restenosis in the left circumflex coronary artery. The guidewire was able to cross the lesion; however, the guidewire broke during removal. A snare was used to successfully retrieve the separated segment of the wire. There were no adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802915 ↗
• InjurySep 11, 2026Difficult to Remove; Material Separation; Stretched

  Patient problems: Foreign Body In Patient

  MAUDE report 50737134 ↗
• MalfunctionSep 9, 2026Difficult to Remove; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50701651 ↗
• MalfunctionJul 22, 2026Difficult to Remove; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25904856 ↗
• MalfunctionJul 20, 2026Break; Stretched; Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25875606 ↗
• InjuryJul 17, 2026Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY LESION WITH 90% STENOSIS. A 190 CM 014 HT VERSATURN F GUIDE WIRE WAS ADVANCED. HOWEVER, IT WAS UNABLE TO REACH THE LESION AND BECAME STUCK IN THE ANATOMY. A MICROCATHETER WAS USED TO REMOVE THE GUIDE WIRE. AN ADDITIONAL NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25856525 ↗
• DeathApr 24, 2026Break; Entrapment of Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHEST PAIN AND AN NON-ABBOTT STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY (RCA). A 014 HT VERSATURN GUIDE WIRE (GW) WAS ADVANCED TO BE USED AS A PROTECTIVE GW; HOWEVER, THE GW BECAME ENTRAPPED IN THE MARGINAL BRANCH ORIGINATING FROM THE RIGHT CORONARY ARTERY (RCA). MULTIPLE ATTEMPTS TO RETRIEVE THE GW WERE MADE BUT ALL WERE UNSUCCESSFUL. THE ATTEMPTS TO RETRIEVE THE ENTRAPPED GW CAUSED THE GW TO FRACTURE. THEN TWISTED UNSPECIFIED GUIDE WIRES WERE USED TO SNARE THE FRACTURED GW. THE FRACTURED GW WAS FREED FROM THE MARGINAL BRANCH; HOWEVER, THE FRACTURED GW AND THE TWISTED GUIDE WIRES REMAINED TRAPPED IN THE RCA, RESULTING IN THE GUIDE WIRES TO BECOME ENTANGLED WITH THE PREVIOUSLY IMPLANTED STENT. AS A RESULT, THE IMPLANTED STENT BECAME STRUCTURALLY COMPROMISED. ANGIOGRAPHY SHOWED IN-STENT RE-OCCLUSION OF THE RIGHT CORONARY ARTERY, ASSOCIATED WITH DISSECTION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE, WITH PRESERVED RESPIRATORY STATUS AND ELECTRICAL STABILITY (NO ST-SEGMENT ELEVATION, NO RHYTHM DISTURBANCES). THE GUIDING CATHETER WAS REMOVED, WITH THE ENTRAPPED GUIDEWIRES LEFT IN PLACE FOR PATIENT TRANSFER TO EMERGENCY SURGERY TO

  Patient problems: Unspecified Heart Problem

  MAUDE report 24975318 ↗
• MalfunctionJan 27, 2026Peeled/Delaminated; Material Too Rigid or Stiff; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH 90% STENOSIS AND NOTED TORTUOSITY AND CALCIFICATION. THE VERSATURN GUIDE WIRE WAS USED AND THE TIP BECAME DEFORMED AFTER SHAPING. THE SURFACE COATING WAS NOTED TO BE SHEDDED, THERE WAS STIFFNESS AND FRICTION NOTED WITH THE ANATOMY AS WELL. THE DEVICE WAS REPLACED WITH AN UNSPECIFIED WIRE. THERE WERE NO ADVERSE EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193477 ↗
• MalfunctionJan 14, 2026Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE VERSATURN GUIDE WIRE TIP BECAME STUCK IN THE ANATOMY DURING REMOVAL. THE WIRE WAS REMOVED INDEPENDENTLY, WITHOUT ANY FRACTURE OR SEPARATION. A NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073166 ↗
• MalfunctionJan 2, 2026Break; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, IT WAS NOTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 70% STENOSED. UPON REMOVAL OF THE HT VERSATURN GUIDE WIRE, RESISTANCE WAS NOTED WITH AN UNSPECIFIED STENT. FORCE WAS APPLIED TO REMOVE THE GUIDE WIRE. UPON REMOVAL, THE GUIDE WIRE TIP WAS NOTED TO UNRAVEL AND THE GUIDE WIRE COILS STRETCHED. 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 23949920 ↗
• MalfunctionJan 2, 2026Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 99% STENOSED. THE 190CM 014 HT VERSATURN GUIDEWIRE WAS ENTRAPPED IN THE CALCIFIED LESION MAKING IT DIFFICULT TO REMOVE; HOWEVER, WAS WITHDRAWN WITH FORCE. UPON REMOVAL, THE TIP OF THE GUIDEWIRE WAS NOTED TO BE SPIRAL-SHAPED/WAVY AND COULD NOT BE RE-SHAPED. A NEW VERSATURN GUIDEWIRE WAS USED TO 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 23946117 ↗
• MalfunctionDec 16, 2025Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT WHEN THE TWO VERSATURN GUIDE WIRES WERE REMOVED FROM THE PACKAGING, AN ABNORMAL AREA WAS NOTED APPROXIMATELY 45MM FROM THE TIP, THE COILS WERE BROKEN. THEREFORE THE GUIDE WIRES WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO THE INITIALLY FILED REPORTS, ADDITIONAL INFORMATION WAS RECEIVED. A PICTURE OF THE GUIDE WIRES NOTED THE TIP COILS WERE STRETCHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815810 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT WHEN THE TWO VERSATURN GUIDE WIRES WERE REMOVED FROM THE PACKAGING, AN ABNORMAL AREA WAS NOTED APPROXIMATELY 45MM FROM THE TIP, THE COILS WERE BROKEN. THEREFORE, THE GUIDE WIRES WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO THE INITIALLY FILED REPORTS, ADDITIONAL INFORMATION WAS RECEIVED. A PICTURE OF THE GUIDE WIRES NOTED THE TIP COILS WERE STRETCHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815776 ↗
• MalfunctionNov 13, 2025Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE .014 HT VERSATURN GUIDE WIRE MET RESISTANCE WITH A PREVIOUSLY IMPLANTED STENT WHEN ATTEMPTING TO ADVANCED. DURING REMOVAL THE TIP OF THE GUIDE WIRE SNAGGED ON IMPLANTED STENT AND BECAME KINKED. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547822 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT DURING PREPARATION, THE TIP OF A 014 HI-TORQUE (HT) VERSATURN GUIDEWIRE WAS FOUND BROKEN. A NEW HT VERSATURN GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT, AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23528173 ↗

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