HI-TORQUE TURNTRAC 1020013Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648222702), received between Jun 22, 2018 and Aug 28, 2026 — classified as 1 death, 9 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 16 most recent of 16 reports, 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 ↗
• 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 ↗
• InjuryJun 26, 2023Break; Difficult to Remove; Material Separation; Stretched; Break; Difficult to Remove; Material Separation; Stretched

  SUBSEQUENT TO THE PREVIOUSLY FILE REPORT, ADDITIONAL INFORMATION WAS PROVIDED THAT AN UNSPECIFIED BALLOON USED TO EMBED THE TIP TO THE VESSEL WALL. THERE WAS NO ADVERSE PATIENT SEQUELA, NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 17204536 ↗
• InjuryFeb 24, 2023Break; Entrapment of Device; Material Separation; Stretched; Failure to Advance; Break; Entrapment of Device; Material Separation; Stretched; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A SOFT LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PATIENT HAD ST ELEVATED MYOCARDIAL INFARCTION (STEMI). THE 014 HT TURNTRAC DEVICE WAS BEING ADVANCED THROUGH THE OCCLUSION, WHEN IT BECAME STUCK AND WAS NOT ABLE TO MOVE FORWARD. A BALLOON AND A NEW GUIDE WIRE WERE USED TO DILATE THE LESION IN ORDER TO BE ABLE TO WITHDRAW THE TURNTRAC GUIDE WIRE. AFTER BEING REMOVED, THE DISTAL TIP WAS NOTED TO BE SEPARATED. THE COILS WERE STRETCHED AND THE WIRE WAS DAMAGED. ANOTHER NON-ABBOTT WIRE WAS USED TO COMPLETE THE PROCEDURE. A CLINICALLY SIGNIFICANT DELAY WAS NOTED DUE TO THE NEED FOR BALLOON INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16438196 ↗
• DeathNov 7, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED, HEAVILY TORTUOUS, 70% STENOSED LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE TURNTRAC GUIDE WIRE WAS BEING REMOVED AFTER STENTING IN THE POSTERIOR DESCENDING AND RIGHT CORONARY ARTERIES (RCA) AND THE DISTAL PORTION SEPARATED AND REMAINED IN THE RCA. THERE WAS RESISTANCE WITH THE STENT NOTED DURING REMOVAL OF THE TURNTRAC GUIDE WIRE AFTER STENT IMPLANT. THE COILS WERE LOST AND COULD NOT BE RETRIEVED. AFTER A WHILE THE FLOW OF THE RCA BECAME SLOW AND THE PATIENT BECAME UNSTABLE DUE TO A DROP IN BLOOD PRESSURE. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL. THE PATIENT EXPIRED 5-6 DAYS LATER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Ischemia; Low Blood Pressure/ Hypotension

  MAUDE report 15747814 ↗
• MalfunctionJun 10, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. THE TURNTRAC GUIDE WIRE WAS ADVANCED TO THE LESION WITHOUT ISSUE. HOWEVER, IT WAS NOTED THAT THE GUIDE WIRE UNRAVELED. IT WAS DECIDED TO BE REMOVED, AND ALTHOUGH RESISTANCE DURING REMOVAL WAS MET WITH AN UNSPECIFIED SOURCE, THE GUIDE WIRE WAS ABLE TO BE REMOVED. ANOTHER 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14654887 ↗
• InjuryDec 14, 2021Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED, DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA). AN 014 HT TURNTRAC GUIDE WIRE (GW) WAS ADVANCED INTO THE POSTERIOR LATERAL BRANCH AND POSITIONED TO ADD SUPPORT IN THE ARTERY. DURING REMOVAL OF THE GW, IT WAS NOTED THAT THE DISTAL PORTION SEPARATED AND POSSIBLY SOME COATING PEELED FROM THE WIRE. THE SEPARATED WIRE AND COATING WERE SNARED AND REMOVED FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION REGARDING THIS ISSUE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006754 ↗
• InjurySep 20, 2021Break; Entrapment of Device; Material Separation; Stretched; Improper or Incorrect Procedure or Method; Break; Entrapment of Device; Material Separation; Stretched; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 014 HT TURNTRAC GUIDE WIRE (GW) WAS ADVANCED TO THE LESION AND TORQUED, WHEN THE TIP OF THE WIRE WAS NOTED AS STUCK IN THE VESSEL AND BECAME BENT. THE PHYSICIAN THEN ADVANCED A NON-ABBOTT CATHETER TO ATTEMPT TO STRAIGHTEN THE BEND OUT AND THE GW SEPARATED INTO 2 PIECES. A SNARE WAS THEN USED TO REMOVE THE SEPARATED GW PIECE. UPON REMOVAL, THE CORE WAS BROKEN, AND THE TIP COILS WERE ELONGATED. A NON-ABBOTT GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12500055 ↗
• InjuryAug 25, 2021Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND HEAVILY TORTUOUS VESSEL IN THE LEFT MAIN TO LEFT ANTERIOR DESCENDING (LAD) ARTERIES. THE HI-TORQUE (HT) TURNTRAC GUIDE WIRE HAD RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT TO THE LESION. RESISTANCE WAS ALSO FELT WITH REMOVAL AND THE TIP SEPARATED WITHIN THE PATIENT'S ANATOMY POSSIBLY AS A RESULT OF RESISTANCE/ INTERACTION WITH A DEPLOYED STENT OR WITH THE CALCIFIED PLAQUE. THE TIP (ABOUT 12 CM) WAS RETRIEVED BY A MICROCATHETER. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND THERE WAS NO REPORTED SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12366431 ↗
• InjurySep 28, 2020Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, MILDLY CALCIFIED DE NOVO DISTAL RIGHT CORONARY ARTERY (RCA) TO THE PROXIMAL POSTERIOR LEFT VENTRICULAR WALL (RPL) THAT WAS 90% STENOSED. THE HI-TORQUE TURN TRAC GUIDE WIRE WAS ADVANCED TO THE LESION. PRE-DILATATION WAS PERFORMED BY A 2X20MM NON-ABBOTT BALLOON. THEN A 2.25X18MM NON-ABBOTT STENT WAS ADVANCED. DURING REPOSITION OF THE GUIDE WIRE FROM THE RPL BEFORE DEPLOYMENT OF THE STENT, THE GUIDE WIRE WAS UNABLE TO BE PULLED BACK DUE TO RESISTANCE WITH ANATOMY. THE STENT AND GUIDE WIRE HAD TO BE REMOVED TOGETHER OUT FROM THE GUIDING CATHETER. ONCE REMOVED, IT WAS NOTED THAT THE DISTAL TIP OF THE GUIDE WIRE WAS STRETCHED AND SOME DISTAL WIRE REMAINED IN THE ANATOMY. BALLOON ANGIOPLASTY WAS PERFORMED TO SUCCESSFULLY COMPLETE THE PROCEDURE AT THE TIME AS TIMI FLOW LL WAS NOTED. AN INTERVENTION WAS PERFORMED ON (B)(6) 2020 TO DEPLOY A STENT AND EMBED THE SEPARATED GUIDE WIRE PIECE. HOSPITALIZATION WAS PROLONGED DUE TO THE SEPARATED GUIDE WIRE PIECE. A CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10593463 ↗
• MalfunctionDec 12, 2019Break; Peeled/Delaminated; Device Difficult to Setup or Prepare; Failure to Advance; Break; Peeled/Delaminated; Device Difficult to Setup or Prepare; Failure to Advance

  SUBSEQUENT TO THE INITIAL 30-DAY MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: AFTER A FAILED ATTEMPT TO CROSS THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY TORTUOUS AND MODERATELY CALCIFIED, THE DEVICE WAS REMOVED FOR RESHAPING. DURING THE RESHAPING PROCESS, THE GUIDEWIRE REMAINED IN ONE PIECE, BUT THE CORE DETACHED. THE DEVICE WAS NOT USED AGAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9462749 ↗
• InjuryFeb 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HI-TORQUE TURNTRAC GUIDE WIRE WAS USED AND A DISSECTION WAS NOTED. AN UNSPECIFIED STENT WAS DEPLOYED AND SUCCESSFULLY TREATED THE DISSECTION, AND THE PROCEDURE CONCLUDED WITH NO FURTHER COMPLICATIONS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 8348749 ↗
• MalfunctionJun 25, 2018Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CIRCUMFLEX ARTERY WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION. A HI-TORQUE TURNTRAC GUIDE WIRE BECAME CAUGHT WITH A MICRO-CATHETER DURING REMOVAL. BOTH DEVICES WERE REMOVED FROM THE PATIENT AS A SINGLE UNIT. REPORTEDLY, THE DISTAL PART OF THE GUIDE WIRE WAS STICKING OUT AND IT WAS PULLED OUT FROM THE DISTAL END WHEN THE TIP BECAME DETACHED OUTSIDE THE PATIENT'S ANATOMY. 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 7635301 ↗
• MalfunctionJun 22, 2018Kinked; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A BIFURCATION LESION IN THE LEFT ANTERIOR DESCENDING DIAGONAL BRANCH. DURING SHAPING OF THE TURNTRAC GUIDE WIRE, THE GUIDE WIRE TIP KINKED, HOWEVER THE GUIDE WIRE WAS CONTINUED TO BE USED. THE GUIDE WIRE WAS ADVANCED AND A STENT WAS IMPLANTED. UPON REMOVAL OF THE GUIDE WIRE, THE GUIDE WIRE WAS CAUGHT ON A STENT AND RESISTANCE WAS FELT. THE GUIDE WIRE WAS REMOVED WITHOUT FURTHER ISSUES. 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 7630844 ↗