HI-TORQUE POWERTURN 1044595Recalls & reported problems
Abbott Vascular Inc. · HI-TORQUE POWERTURN Guide Wire w/Hydrophilic Coating .014" Straight Tip 300 cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648173998), received between Sep 14, 2018 and Sep 14, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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
- Deformation Due to Compressive Stress1
- Difficult to Remove1
- Improper or Incorrect Procedure or Method1
- Stretched1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2018Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PEDAL ARTERY WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION. A HT POWERTURN GUIDEWIRE WAS ADVANCED TO THE LESION WITH NO REPORTED RESISTANCE. WHEN THE GUIDEWIRE REACHED THE LESION AT THE SITE OF A COLLATERAL VESSEL, A KINK OCCURRED. AN UNSPECIFIED BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER THE WIRE AND LESION WAS DILATED. ON REMOVAL OF THE BDC, RESISTANCE WITH THE GUIDEWIRE WAS NOTED. AS A RESULT, THE GUIDEWIRE AND BDC HAD TO BE REMOVED AS A SINGLE UNIT. ON INSPECTION OF THE GUIDEWIRE OUTSIDE OF THE ANATOMY, THE COILS WERE NOTED TO BE UNRAVELED. THE CORE OF THE GUIDEWIRE WAS INTACT AND THE DEVICE REMAINED IN ONE PIECE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ADDITIONAL NON-ABBOTT GUIDEWIRE. 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 7878470 ↗
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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