HI-TORQUE PILOT 1010484-HRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE PILOT 150 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 08717648073939), received between Nov 10, 2021 and Feb 12, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Difficult to Advance” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Advance1
- Difficult to Remove1
- Material Separation1
Patient problems
- Device Embedded In Tissue or Plaque1
- Obstruction/Occlusion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). DURING PERCUTANEOUS CORONARY INTERVENTION (PCI), AFTER THE BALLOON CROSSED THE HEAVILY CALCIFIED RCA, THE PHYSICIAN NOTED THERE WERE SOME UNKNOWN FLOW ISSUES, POSSIBLY DUE TO THE RUNTHROUGH OR PILOT WIRE GUIDE WIRES, WHILE REWIRING THE ARTERY AFTER SUBINTIMAL. SURGERY WAS PERFORMED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Obstruction/Occlusion
MAUDE report 18684670 ↗InjuryNov 10, 2021Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ANTERIOR TIBIAL ARTERY. THE .014 HI-TORQUE PILOT GUIDE WIRE MET RESISTANCE DURING ADVANCEMENT AND THE TIP SEPARATED. RESISTANCE WAS ALSO NOTED DURING REMOVAL. THE TIP REMAINS EMBEDDED IN THE VESSEL. THE PATIENT UNDERWENT AN AMPUTATION AS IT WAS NOT POSSIBLE TO TREAT THE LESION. ADDITIONALLY, IT WAS STATED THE PATIENT WAS ALREADY A CANDIDATE FOR AMPUTATION PRIOR TO THE ENDOVASCULAR TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 12789008 ↗
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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