HI-TORQUE PILOT 1010483-HRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE PILOT 50 Guide Wire .014 Straight Tip 3.0 cm x 300 cm · Class 2
All models of HI-TORQUE PILOT (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648073915), received between Jul 18, 2019 and Feb 24, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Separation” (2 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 16, 2026.
Most reported problems
Device problems
- Material Separation2
- Difficult to Remove1
Patient problems
- Embolism1
- Foreign Body In Patient1
- Vessel Or Plaque, Device Embedded In1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2023Material Separation; Material Separation
USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: "DESCRIBE THE EVENT OR PROBLEM: DURING A LEFT HEART CATH, THE 3CM TIP OF A PILOT 50 GUIDE WIRE DISCONNECTED FROM THE REST OF THE WIRE. THE TIP REMAINS IN THE PATIENT. PATIENT STABLE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: LEFT HEART CATH WITH INTERVENTION. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) : DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)" NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 16439276 ↗InjuryJul 18, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) /POPLITEAL ARTERY THAT WAS NON-TORTUOUS AND MODERATELY CALCIFIED. DURING REMOVAL OF THE HI-TORQUE PILOT 50, RESISTANCE WAS NOTED, AND THE WIRE TIP FRACTURED WHILE IN THE SFA. THE SEPARATED SEGMENT REMAINED IN THE ARTERY WHERE IT MIGRATED TO THE MID-POPLITEAL ARTERY. A SUPERA STENT WAS DEPLOYED TO KEEP THE FRACTURED SEGMENT OF THE PILOT GUIDE WIRE IN PLACE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Embolism; Vessel Or Plaque, Device Embedded In
MAUDE report 8805139 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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