HI-TORQUE TURNTRAC 1020009Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648222627), received between Feb 26, 2019 and Aug 7, 2025 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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DILATATION, AN ATTEMPT WAS MADE TO REMOVE ONLY THE SAPPHIRE BALLOON BUT THE TURNTRAC GUIDE WIRE WAS UNINTENTIONALLY WITHDRAWN.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 ↗
• MalfunctionMar 1, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THE TURNTRAC AND OPTICAL COHERENCE TOMOGRAPHY (OCT) DRAGONFLY OPSTAR IMAGING CATHETER WERE DELIVERED WITHOUT ANY PROBLEMS DISTAL INTO THE LEFT ANTERIOR DESCENDING (LAD) LESION. HOWEVER, AFTER THE THIRD SUCCESSFUL IMAGE, REMOVAL OF THE DRAGONFLY CATHETER WAS NOT POSSIBLE, IT WAS STUCK WITH THE TURNTRAC GUIDEWIRE. BOTH THE TURNTRAC AND THE DRAGONFLY WERE REMOVED TOGETHER. THE TURNTRAC WAS INSPECTED OUTSIDE THE PATIENT ANATOMY, AND IT WAS OBSERVED THAT THE DISTAL TIP OF THE TURNTRAC WAS BROKEN AND IT SEEMS LIKE THE COILS ARE NOT IN THE CORRECT POSITION. THE TURNTRAC WAS STUCK IN THE OCT DRAGONFLY CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822347 ↗
• InjuryFeb 15, 2024Break; Peeled/Delaminated; Material Separation; Material Too Soft/Flexible; Break; Peeled/Delaminated; Material Separation; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT MODERATELY CALCIFIED RIGHT CORONARY ARTERY THAT IS 50-75% STENOSED. THE 014 HT TURNTRAC FLEX GUIDE WIRE WAS PLACED IN THE DISTAL AREA OF THE VESSEL. A 2.0X15MM BALLOON WAS DELIVERY OVER THE TURNTRAC GUIDE WIRE; HOWEVER, BEFORE THE BALLOON WAS DILATED, THE GUIDE WIRE WAS NO LONGER IN THE CORRECT POSITION. WHEN ATTEMPTING TO REPOSITION IT THE TIP OF GUIDE WIRE COULD NOT LONGER BE CONTROLLABLE; THEREFORE, THE BALLOON AND GUIDE WIRE HAD TO BE REMOVED TOGETHER. ONCE OUTSIDE OF THE ANATOMY, IT WAS OBSERVED THAT THE DISTAL TIP OF THE GUIDE WIRE WAS BROKEN (COILS AND COATING), AND GUIDE WIRE PIECES [COATING] WERE NOTED ON THE BALLOON. CONTRAST MEDIUM ACCUMULATION WAS NOTED IN X-RAY, WHICH SUGGESTED A PERFORATION. AN UNKNOWN STENT WAS PLACED TO SEAL THE PERFORATION. A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Perforation of Vessels

  MAUDE report 18717412 ↗
• InjuryMar 7, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH 70% STENOSIS. DURING STENT IMPLANTATION, THE TURNTRAC GUIDE WIRE TIP SEPARATED AND WAS RETRIEVED USING A SNARE DEVICE. THERE WAS NO RESISTANCE DURING ADVANCEMENT OR REMOVAL. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497645 ↗
• MalfunctionMay 17, 2022Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED RIGHT CORONARY ARTERY THAT WAS 99% STENOSED. THE TURNTRAC FLEX GUIDE WIRE WAS ADVANCED TO THE LESION WITHOUT ISSUE. HOWEVER, WHEN ADVANCING THE BALLOON OVER THE GUIDE WIRE, RESISTANCE WAS MET AND THEREFORE THE PHYSICIAN DECIDED TO REMOVE BOTH THE BALLOON AND GUIDE WIRE. WHEN WITHDRAWING THE DEVICES, THE PHYSICIAN THEN NOTED THE GUIDE WIRE WITH TIP COILS SEPARATION, CORE INTACT WITH THE GUIDE WIRE REMAINING IN ONE PIECE. NO PART OF THE GUIDE WIRE REMAINED IN THE ANATOMY AS IT WAS REMOVED ENTIRELY IN ONE PIECE. A NEW TURNTRAC GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO NOTED RESISTANCE DURING WITHDRAWAL. 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 14416151 ↗
• InjuryApr 1, 2022Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 50-70% HEAVILY CALCIFIED LESION IN THE MODERATE TO HEAVILY TORTUOUS CIRCUMFLEX (CX) ARTERY. THE 014 HI-TORQUE TURNTRAC FLEX GUIDE WIRE (GW) WAS ADVANCED AND POSITIONED. AFTER LESION PRE-DILATATION AND IMPLANTATION OF TWO DRUG ELUTING STENTS, THE GW BECAME JAILED WITH ONE OF THE IMPLANTED STENTS AND SEPARATED. AN ATTEMPT TO SNARE THE SEPARATED GW PIECE WAS UNSUCCESSFUL, SO A DRUG ELUTING STENT (DES) WAS USED TO EMBED THE PIECE OF GW IN THE VESSEL WALL. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13973015 ↗
• MalfunctionJan 4, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS FIRST OBTUSE MARGINAL ARTERY THAT IS 90% STENOSED. THE 3.25X12MM NC TREK BALLOON DILATATION CATHETER (BDC) HAD BEEN FULLY DEFLATED, BUT WAS STUCK WITH THE 014 HI-TORQUE TURNTRAC FLEX GUIDE WIRE AS BDC WAS MOVED. THE GUIDE WIRE AND THE BALLOON WERE REMOVED TOGETHER AS ONE UNIT. ANOTHER NC TREK WAS USED WITH A NON-ABBOTT GUIDE WIRE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13155691 ↗
• MalfunctionDec 10, 2021Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CIRCUMFLEX (CX) LESION. TWO TURNTRAC GUIDE WIRES (GW) PLACED, ONE IN THE LEFT ANTERIOR DESCENDING ARTERY AND THE OTHER IN THE CX ARTERY. NO RESISTANCE IN PLACING THE GW'S. ONCE THE PROCEDURE WAS COMPLETED AND DURING REMOVAL OF BOTH GUIDE WIRES, IT WAS NOTED THAT THE TURNTRAC OF THE CX WAS STRETCHED OUT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS NOTED THAT THE CORE WAS SEPARATED (NOT IN TWO SEPARATE PIECES) 1.7CM PROXIMAL TO THE TIP SOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12976155 ↗
• InjuryAug 4, 2021Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). AN UNSPECIFIED STENT WAS IMPLANTED IN THE MID RCA; HOWEVER, DURING THE REMOVAL OF A .014 HT TURNTRAC FLEX GUIDE WIRE WHICH WAS BEING USED AS A BUDDY GUIDE WIRE, IT SEPARATED. THE 3CM SEPARATED PORTION REMAINED IN THE RIGHT VENTRICULAR BRANCH (RV) AND UNDERNEATH THE STENT STRUT AT THE MID RCA. THE PATIENT IS CONTINUING TO BE MONITORED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12277487 ↗
• MalfunctionOct 11, 2019Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL CIRCUMFLEX ARTERY. A HI TORQUE TURNTRAC FLEX GUIDE WIRE WAS TRAPPED BY AN UNSPECIFIED STENT. DURING REMOVAL, THE GUIDE WIRE WAS DESTRUCTURED [UNRAVELED]. THE FINAL PATIENT OUTCOME WAS GOOD. 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 9179333 ↗
• MalfunctionAug 23, 2019Break; Material Separation; Stretched; Difficult to Advance; Break; Material Separation; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY STENOSED LESION IN THE MID CIRCUMFLEX ARTERY. RESISTANCE ADVANCING A 014 HT TURNTRAC FLEX GUIDE WIRE THROUGH THE GUIDING CATHETER WAS FELT AND WHEN THE WIRE WAS REMOVED IT WAS NOTED THAT THE WIRE WAS UNRAVELED AND THE COILS DETACHED. 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 8927580 ↗
• MalfunctionFeb 26, 2019Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO, ECCENTRIC LESION IN THE OBTUSE MARGINAL BRANCH OF THE LEFT CIRCUMFLEX CORONARY ARTERY WITH HEAVY TORTUOSITY, HEAVY CALCIFICATION AND 99% STENOSIS. A HI-TORQUE TURNTRAC FLEX GUIDE WIRE WAS ADVANCED; HOWEVER, FAILED TO CROSS THE LESION DUE TO THE ANATOMY. RESISTANCE WAS ALSO MET WITH THE ANATOMY OF REMOVAL OF THE GUIDE WIRE AS AN INDEPENDENT UNIT. A NON-ABBOTT GUIDE WIRE SUCCESSFULLY CROSSED THE LESION TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8372413 ↗
• MalfunctionFeb 26, 2019Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CONCENTRIC, DE NOVO LESION IN THE PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY WITH HEAVY TORTUOSITY, MODERATE CALCIFICATION AND 99% STENOSIS. A HI-TORQUE TURNTRAC FLEX GUIDE WIRE WAS ADVANCED; HOWEVER, FAILED TO CROSS THE LESION DUE TO THE PATIENT ANATOMY. RESISTANCE WITH THE ANATOMY WAS ALSO FELT ON REMOVAL OF THE GUIDE WIRE AS AN INDEPENDENT UNIT. A NON-ABBOTT GUIDE WIRE WAS USED TO SUCCESSFULLY CROSS THE LESION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8372399 ↗