HI-TORQUE TURNTRAC 1020010Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648222641), received between Aug 10, 2018 and Nov 27, 2024 — classified as 4 injuries, 11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionNov 28, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE 014 HT TURNTRAC FLEX GUIDE WIRE FAILED TO CROSS THE LESION DUE TO ANATOMY. IT WAS NOTED RESISTANCE WITH ANATOMY WAS FELT DURING REMOVAL OF THE GUIDE WIRE. 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 15874799 ↗
• MalfunctionAug 22, 2022Break; Difficult to Remove; Failure to Advance; Break; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. THE 014 HT TURNTRAC FLEX GUIDEWIRE (GW) (LOT#1101861) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, AFTER SEVERAL ATTEMPTS THE GW FAILED TO CROSS DUE TO THE ANATOMY AND THE TIP OF THE GW BROKE. THE GW WAS REMOVED WITH DIFFICULTY DUE TO ANATOMY. THE GW REPLACED WITH ANOTHER SAME SIZE TURNTRAC GW (LOT#1102161). THE SECOND GW ALSO FAILED TO CROSS DUE TO THE ANATOMY AND THE TIP OF THE SECOND GW ALSO BROKE. THE SECOND GW WAS ALSO REMOVED WITH DIFFICULTY DUE TO THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT GW WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272325 ↗
• MalfunctionAug 22, 2022Break; Difficult to Remove; Failure to Advance; Break; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. THE 014 HT TURNTRAC FLEX GUIDEWIRE (GW) (LOT#1101861) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, AFTER SEVERAL ATTEMPTS THE GW FAILED TO CROSS DUE TO THE ANATOMY AND THE TIP OF THE GW BROKE. THE GW WAS REMOVED WITH DIFFICULTY DUE TO ANATOMY. THE GW REPLACED WITH ANOTHER SAME SIZE TURNTRAC GW (LOT#1102161). THE SECOND GW ALSO FAILED TO CROSS DUE TO THE ANATOMY AND THE THE TIP OF THE SECOND GW ALSO BROKE. THE SECOND GW WAS ALSO REMOVED WITH DIFFICULTY DUE TO THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT GW WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272270 ↗
• MalfunctionJun 4, 2021Break; Material Separation; Stretched; Break; Material Separation; Stretched

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THE .014 HT TURNTRAC FLEX GUIDE WIRE DID NOT SEPARATE, THE TIP COILS STRETCHED. THE GUIDE CATHETER WAS SIMPLY ADVANCED TO THE STRETCHED GUIDE WIRE COILS AND THE GUIDE WIRE AND GUIDE CATHETER WERE REMOVED TOGETHER AS A UNIT. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS IDENTIFIED THE CORE WAS SEPARATED, BUT THE GUIDE WIRE WAS IN ONE PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939345 ↗
• InjuryJun 30, 2020Entrapment of Device; Difficult to Remove; Material Separation; Stretched; Entrapment of Device; Difficult to Remove; Material Separation; Stretched

  ADDITIONAL REPORTED INFORMATION INDICATES THAT THE TIP AND COILS REMAIN IN THE ANATOMY, AS THEY ARE CAUGHT BETWEEN THE IMPLANTED STENT AND VESSEL WALL AND IT WAS DIFFICULT TO WITHDRAW THEM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 10212986 ↗
• MalfunctionMay 19, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NSTEMI AND THE PROCEDURE WAS TO TREAT THE CIRCUMFLEX AND LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERIES. THE PROCEDURE REQUIRED TWO TURNTRAC GUIDE WIRES IN THE PATIENT. ONE OF THE GUIDE WIRES WAS BEING WITHDRAWN AS THE OTHER GUIDE WIRE WAS POSITIONED IN THE NEEDLE IN THE Y CONNECTOR OUTSIDE THE PATIENT. WHEN THE DISTAL PORTION OF THE GUIDE WIRE BEING REMOVED CAME IN CONTACT WITH THE NEEDLE, THE DISTAL PORTION DISINTEGRATED INTO FILAMENTS. THE DISTAL PORTION OF THE GUIDE WIRE AND THE DISINTEGRATED PART WERE EASILY REMOVED BY LOOSENING THE Y CONNECTOR AND DISCONNECTING IT FROM THE DISTAL END OF THE GUIDING CATHETER. ALL PARTS WERE OUTSIDE OF THE PATIENT WHEN THIS OCCURRED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PHYSICIAN NOTED THAT SHE SHOULD HAVE FIRST REMOVED THE TURNTRAC GUIDE WIRE THAT WAS IN THE NEEDLE BEFORE ATTEMPTING TO REMOVE THE OTHER GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10072979 ↗
• InjuryAug 15, 2019Break; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Failure to Advance; Break; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Failure to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE TURNTRAC FLEX GUIDE WIRE CORE WAS SEPARATED DURING REMOVAL, BUT THE COILS WERE INTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8898443 ↗
• MalfunctionMar 4, 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, CONCENTRIC LESION IN THE DISTAL RIGHT CORONARY ARTERY WITH MODERATE 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 WAS ALSO MET WITH THE ANATOMY ON REMOVAL OF THE GUIDE WIRE AS AN INDEPENDENT UNIT. THE PROCEDURE WAS SUCCESSFULLY CONTINUED WITH A NON-ABBOTT GUIDE WIRE. 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 8386888 ↗
• MalfunctionFeb 25, 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 CONCENTRIC LESION IN THE 1ST MARGINAL CORONARY ARTERY WITH HEAVY TORTUOSITY AND HEAVY CALCIFICATION. FOLLOWING PLACEMENT OF A NON-ABBOTT GUIDING CATHETER, 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 MET ON REMOVAL OF THE GUIDE WIRE AS AN INDEPENDENT UNIT. AN UNSPECIFIED NON-ABBOTT GUIDE WIRE SUCCESSFULLY CROSSED THE LESION TO CONTINUE THE PROCEDURE. 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 8367402 ↗
• MalfunctionNov 15, 2018Material Separation; Stretched; Difficult to Advance; Material Separation; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN A MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) THAT DID NOT HAVE ANY TORTUOSITY. A 190 CM TURNTRAC GUIDE WIRE WAS ADVANCED TO THE LESION AND AN UNSPECIFIED STENT WAS IMPLANTED. THEN, AN UNSPECIFIED FLOPPY GUIDE WIRE WAS INSERTED IN A BIFURCATION BRANCH. AN ATTEMPT WAS THEN MADE TO ADVANCE A 3.5 X 18 MM XIENCE PROX STENT DELIVERY SYSTEM (SDS) TO THE LESION; HOWEVER, THE SDS WAS NOT ABLE TO ADVANCE OVER THE TURNTRAC GUIDE WIRE. IT WAS THOUGHT THAT THE SOLDER PART WAS DAMAGED. THE FLOPPY GUIDE WIRE WAS THEN REMOVED; HOWEVER, THE SDS WAS STILL NOT ABLE TO ADVANCE OVER THE TURNTRAC GUIDE WIRE. IT WAS ALSO NOTED THAT THE COILS OF THE GUIDE WIRE WERE STRETCHED. IT WAS REPORTED THAT THE STRETCHED COILS COULD HAVE OCCURRED WHEN THE GUIDE WIRE WAS INSERTED INSIDE THE ANATOMY AND THAT IT WAS NOT CAUSED BY THE XIENCE PROX SDS. THE TURNTRAC GUIDE WIRE WAS THEN REPLACED WITH AN ANOTHER UNSPECIFIED TURNTRAC GUIDE WIRE, AND THE SAME SDS WAS ABLE TO ADVANCE OVER IT TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8075874 ↗
• InjurySep 28, 2018Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED DE NOVO LESION IN THE CORONARY ARTERY. A HI-TORQUE TURNTRAC GUIDE WIRE WAS ADVANCED TO SUPPORT A SIDE BRANCH; HOWEVER, RESISTANCE WITH THE ANATOMY WAS FELT AND THE GUIDE WIRE SEPARATED. THE SEPARATED WIRE PORTION WAS REMOVED WITH A SNARE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BALLOON ANGIOPLASTY AND THE PATIENT IS FINE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7920129 ↗
• MalfunctionAug 22, 2018Peeled/Delaminated; Material Too Soft/Flexible; Peeled/Delaminated; Material Too Soft/Flexible

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY TORTUOUS, HEAVILY CALCIFIED, 80% STENOSED, DE NOVO, MID RIGHT CORONARY ARTERY (RCA), AFTER 3.0 X 38 MM NON-ABBOTT STENT IMPLANTATION AND BALLOON DILATATION, THE TURNTRAC GUIDE WIRE WAS NOTED TO BE PROLAPSED AT A SAPHENOUS VEIN GRAFT (SVG). A DIFFERENT NON-ABBOTT GUIDE WIRE WAS ADVANCED NEXT TO THE TURNTRAC AND A MICROCATHETER USED AS A SUPPORT TO RETRIEVE THE TURNTRAC. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE VESSEL. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. A NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. RETURN DEVICE ANALYSIS REVEALED INTERMITTENT SCRAPED AND FLAKED TEFLON COATING NOTED ON THE COILS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7807315 ↗
• MalfunctionAug 10, 2018Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 190 CM TURNTRAC GUIDE WIRE WAS USED ALONG WITH AN UNSPECIFIED NON-ABBOTT BALLOON DILATATION CATHETER, WHICH WAS INFLATED AT 30 ATMOSPHERES. HOWEVER, RESISTANCE WAS NOTED BETWEEN THE DEVICES DURING ADVANCEMENT AND REMOVAL. THEREFORE, THE GUIDE WIRE WAS REMOVED INDEPENDENTLY AND ANOTHER UNSPECIFIED TURNTRAC 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 Consequences Or Impact To Patient

  MAUDE report 7772312 ↗