HI-TORQUE PILOT 1010481-HJRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE PILOT 150 Guide Wire .014 J Tip 3.0 cm x 190 cm · Class 2
All models of HI-TORQUE PILOT (11)
Data updated Oct 16, 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 08717648073885), received between Jul 24, 2019 and Jul 24, 2019 — classified as 1 injury.
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.
Most reported problems
Device problems
- Difficult to Advance1
- Material Separation1
- Peeled/Delaminated1
Patient problems
- Arrhythmia1
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 24, 2019Peeled/Delaminated; Material Separation; Difficult to Advance; Peeled/Delaminated; Material Separation; Difficult to Advance
SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE MET INITIAL RESISTANCE WITH THE ANATOMY. ALTHOUGH IT WAS REPORTED THAT NO POLYMER PARTICLES WERE LEFT INSIDE THE ARTERY, THERE MAY HAVE BEEN FOREIGN MATERIAL LEFT INSIDE THE ANATOMY. THE PATIENT ALSO DEVELOPED ARRHYTHMIA DURING THE PROCEDURE, HOWEVER THERE IS NO INFORMATION REGARDING TREATMENT. DILATATION OF THE CIRCUMFLEX WAS NOT PERFORMED DUE TO INABILITY TO CROSS THE LESION WITH A NON-ABBOTT BALLOON. THE PROCEDURE WAS STOPPED TO NOT EXCEED THE CONTRAST MEDIA AND RX DOSE. THE DEVICE WAS RECEIVED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Arrhythmia; Foreign Body In Patient
MAUDE report 8823601 ↗
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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