HI-TORQUE TURNTRACRecalls & reported problems across all models

We found 5 models of HI-TORQUE TURNTRAC by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 74 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2018 and Aug 28, 2026 — classified as 1 death, 31 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (37 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 TURNTRAC problems

HI-TORQUE TURNTRAC models

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

• HI-TORQUE TURNTRAC 1020014

  Wire, guide, catheter
  27 reports
• HI-TORQUE TURNTRAC 1020013

  Wire, guide, catheter
  1 death16 reports
• HI-TORQUE TURNTRAC 1020009

  Wire, guide, catheter
  15 reports
• HI-TORQUE TURNTRAC 1020010

  Wire, guide, catheter
  15 reports
• HI-TORQUE TURNTRAC 1020012

  Wire, guide, catheter
  1 report

Recent HI-TORQUE TURNTRAC adverse event reports

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

• MalfunctionAug 28, 2026Difficult or Delayed Positioning

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50505870 ↗
• InjuryJan 2, 2026Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. A SCOREFLEX BALLOON WAS USED. WHEN REMOVING THE SCOREFLEX BALLOON, THE WIRE WAS ALSO REMOVED UNINTENTIONALLY, RESULTING IN THE WIRE RUPTURING [SEPARATION]. BOTH THE BODY AND TIP OF THE WIRE WERE RETRIEVED WITH A SNARE. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23946427 ↗
• MalfunctionDec 1, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (DLAD) ARTERY. THE HI-TORQUE (HT) TURNTRAC GUIDEWIRE WAS ADVANCED TO THE TARGET LESION. A DEVICE WAS ATTEMPTED TO ADVANCE ALONG THE GUIDEWIRE BUT COULD NOT CROSS. THE GUIDEWIRE WAS FOUND TO BE FRAYED [BREAK] UPON INSPECTION. A NON-ABBOTT GUIDEWIRE COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 23686716 ↗
• InjuryOct 15, 2025Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE TURNTRAC GUIDE WIRE WAS USED AS A WORKHORSE; HOWEVER IT COULD NOT CROSS THE PROXIMAL TORTUOSITY SO THE PHYSICIAN DECIDED TO EXCHANGE FOR A NON-ABBOTT WIRE. AFTER REMOVAL OF THE TURNTRAC GUIDE WIRE, IT WAS NOTED THAT THE RADIOPAQUE TIP OF THE WIRE REMAINED IN THE VESSEL. NO RESISTANCE WAS NOTED DURING REMOVAL OF THE WIRE. THE SEPARATED PORTION WAS ULTIMATELY REMOVED AFTER 3 HOURS OF USING A SNARE AND GUIDING CATHETER MANIPULATION. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280827 ↗
• MalfunctionAug 7, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE TORTUOSITY AND 90% STENOSIS. THE TURNTRAC GUIDE WIRE WAS ADVANCED TO THE LESION AND A 2.0X15 MM SAPPHIRE BALLOON WAS ADVANCED TO THE LESION AND INFLATED AFTER INTRAVASCULAR ULTRASOUND WAS PERFORMED. AFTER DILATATION, AN ATTEMPT WAS MADE TO REMOVE ONLY THE SAPPHIRE BALLOON BUT THE TURNTRAC GUIDE WIRE WAS UNINTENTIONALLY WITHDRAWN. IT WAS CONFIRMED THAT THE WIRE HAD BECOME STUCK IN THE WIRE LUMEN OF THE SAPPHIRE BALLOON. A VERSATURN 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 22740276 ↗
• MalfunctionJun 4, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE HT TURNTRAC GUIDE WIRE (GW) WAS ADVANCED TO THE TARGET LESION FOLLOWED BY ADVANCEMENT OF A 2.50X06MM NC TREK NEO BALLOON DILATATION CATHETER (BDC). AFTER INFLATING THE BALLOON TO 12 ATMOSPHERES (ATM), UPON ATTEMPTING TO WITHDRAW THE BDC, RESISTANCE WAS MET AND THE DEVICES WERE STUCK TOGETHER. THE GW WAS UNINTENTIONALLY PULLED OUT ALONG WITH THE BDC. AFTER REMOVAL, AN ATTEMPT WAS MADE TO SEPARATE THE BALLOON FROM THE GUIDEWIRE OUTSIDE THE ANATOMY, BUT IT COULD NOT BE DETACHED. A VERSATURN GW WAS USED TO RE-CROSS THE LESION, AND A NEW NC TREK NEO OF THE SAME SIZE WAS OPENED AND USED FOR ADDITIONAL INFLATION. A 2.50X15MM XIENCE STENT WAS THEN DEPLOYED, COMPLETING 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 22140928 ↗
• MalfunctionMar 21, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX CORONARY ARTERY WITH MILD CALCIFICATION, NO TORTUOSITY AND 75% STENOSIS. THE TURNTRAC FLEX GUIDE WIRE WAS ATTEMPTED TO BE CROSSED FOR SIDE BRANCH PROTECTION; HOWEVER, THE WIRE FAILED TO REACH THE LESION DUE TO THE ANATOMY AND THE WIRE TIP BROKE. THERE WAS NO SIGNIFICANT FORCE APPLIED. 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 21668153 ↗
• InjuryNov 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. THERE WAS NO RESISTANCE NOTED DURING ADVANCEMENT OF THE 0.14 HI-TORQUE TURNTRAC GUIDEWIRE HOWEVER, THE GUIDEWIRE CORE BECAME SEPARATED. THE SEPARATED CORE WAS REMOVED WITH A SNARING DEVICE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799902 ↗
• InjurySep 30, 2024Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A HT TURNTRAC GUIDE WIRE (GW) WAS NOTED TO BE JAILED BY A PREVIOUSLY IMPLANTED STENT IN THE LAD, AND DURING ITS REMOVAL THE GW SNAPPED AT THE DISTAL TIP. THE SEPARATED TIP WAS EMBEDDED TO THE VESSEL WALL BEHIND THE STENT, AND ANOTHER GW WAS USED TO DETERMINE HOW MUCH OF THE SEPARATED PIECE WAS LEFT IN THE LEFT MAIN ARTERY. A CLINICAL DELAY WAS REPORTED. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE DEVICE WAS RECEIVED AND THE PRODUCT RETURN ANALYSIS COULD NOT CONFIRM THE SEPARATED TIP. IT WAS CONFIRMED BY THE ACCOUNT THE REPLACEMENT DEVICE WAS INADVERTENTLY RETURNED WHICH WAS NOTED TO HAVE NO ISSUES DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 20335625 ↗
• MalfunctionSep 27, 2024Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS RIGHT CORONARY ARTERY. THE .014 HT TURNTRAC GUIDE WIRE BECAME TANGLED WITH NON-ABBOTT CATHETER WHEN ATTEMPTING TO REMOVE THE CATHETER. THE GUIDE WIRE AND CATHETER WERE REMOVED TOGETHER AS ONE UNIT. ONCE REMOVED THE TIP OF THE GUIDE WIRE WAS OBSERVED TO BE ROLLED UP. NO OTHER DEVICE WAS USED AS THIS WAS THE END OF THE PROCEDURE. THERE WAS 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 20322728 ↗
• MalfunctionJul 25, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. RESISTANCE WAS MET REMOVING THE HT TURNTRAC GUIDE WIRE. WHEN REMOVED FROM THE ANATOMY THE COILS WERE NOTED TO BE UNRAVELED. 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 19825481 ↗
• MalfunctionJul 18, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT WHEN OPENING THE POUCH OF THE 014 HT TURNTRAC FLEX 190 GUIDE WIRE (GW), A HAIR WAS NOTED TO BE ON THE DISPENSER HOOP WHILE THE DEVICE WAS STILL IN THE BAG. THEREFORE, THE GW WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER TURNTRAC GW WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19773372 ↗
• MalfunctionMay 13, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 100% STENOSED DE NOVO LESION IN THE MID RIGHT CORONARY (MRCA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 014 HT TURNTRAC 190 GUIDE WIRE WAS ATTEMPTED TO CROSS THE TARGET LESION WITH A NON-ABBOTT BALLOON CATHETER; HOWEVER, THE GUIDE WIRE BECAME CAUGHT WITH THE STENOSED LESION. THE GUIDE WIRE WAS PULLED WHILE PUSHING THE BALLOON AND THE MICRO CATHETER AT THAT TIME. ANGIOGRAPHY THEN SHOWED THAT THE COILS OF THE GUIDE WIRE WERE STRETCHED; THEREFORE, SHOCKWAVE THERAPY WAS PERFORMED TO REMOVE THE GUIDE WIRE FROM THE PATIENT. ANOTHER SAME SIZE TURNTRAC GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT BOTH TURNTRAC GUIDE WIRES WERE USED PASSED THE EXPIRATION DATE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305742 ↗
• InjuryMay 13, 2024Entrapment of Device; Stretched; Improper or Incorrect Procedure or Method; Failure to Advance; Entrapment of Device; Stretched; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 100% STENOSED DE NOVO LESION IN THE MID RIGHT CORONARY (MRCA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 014 HT TURNTRAC 190 GUIDE WIRE WAS ATTEMPTED TO CROSS THE TARGET LESION WITH A NON-ABBOTT BALLOON CATHETER; HOWEVER, THE GUIDE WIRE BECAME CAUGHT WITH THE STENOSED LESION. THE GUIDE WIRE WAS PULLED WHILE PUSHING THE BALLOON AND THE MICRO CATHETER AT THAT TIME. ANGIOGRAPHY THEN SHOWED THAT THE COILS OF THE GUIDE WIRE WERE STRETCHED; THEREFORE, SHOCKWAVE THERAPY WAS PERFORMED TO REMOVE THE GUIDE WIRE FROM THE PATIENT. ANOTHER SAME SIZE TURNTRAC GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT BOTH TURNTRAC GUIDE WIRES WERE USED PASSED THE EXPIRATION DATE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305639 ↗
• InjuryMar 8, 2024Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE HT TURNTRAC GUIDE WIRE (GW) WAS ADVANCED TO THE TARGET SITE; HOWEVER, IT FAILED TO CROSS THE LESION DUE TO VESSEL TORTUOSITY. ANOTHER UNSPECIFIED GW WAS ADVANCED AS A BUDDY WIRE FOR SUPPORT, BUT THIS ALSO FAILED TO CROSS THE LESION. UPON WITHDRAWAL OF THE TURNTRAC, THE GW FELT RESISTANCE WITH THE PATIENTS ANATOMY AND THE TIP SEPARATED. THE SEPARATED PIECE WAS RETRIEVED FROM THE LAD USING A SNARE. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT GUIDE WIRE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869305 ↗

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