HI-TORQUE TURNTRAC 1020012Recalls & reported problems
Abbott Vascular Inc. · HI-TORQUE TurnTrac Flex Guide Wire .014" Uncoated Straight Tip 300 cm · Class 2
All models of HI-TORQUE TURNTRAC (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648222689), received between Aug 7, 2020 and Aug 7, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
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
Device problems
- Difficult to Remove1
- Improper or Incorrect Procedure or Method1
- Material Separation1
Patient problems
- Intimal Dissection1
- Vessel Or Plaque, Device Embedded In1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2020Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method
IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE OBTUSE MARGINAL CORONARY ARTERY. THE TURNTRAC GUIDE WIRE WAS ADVANCED AND TWO STENTS WERE IMPLANTED. HOWEVER, RESISTANCE WAS MET WHEN RETRACTING THE GUIDE WIRE, REQUIRING MINIMAL FORCE TO REMOVE. THE GUIDE WIRE TIP SEPARATED, AND A DISSECTION OCCURRED. A STENT WAS IMPLANTED, TREATING THE DISSECTION AND EMBEDDING THE GUIDE WIRE TIP AGAINST THE VESSEL WALL. THE PATIENT HAD NO FURTHER COMPLICATIONS AND WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Intimal Dissection; Vessel Or Plaque, Device Embedded In
MAUDE report 10382853 ↗
Other Wire, guide, catheter devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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