HI-TORQUE ALL STAR 1001740JRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE ALL STAR Guide Wire .014 J Tip 3.0 cm x 190 cm · Class 2
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 08717648025945), received between Sep 23, 2019 and Sep 23, 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 18, 2026.
Most reported problems
Device problems
- Difficult to Advance1
- Material Separation1
- Off-Label Use1
Patient problems
- 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.
InjurySep 23, 2019Off-Label Use; Material Separation; Difficult to Advance; Off-Label Use; Material Separation; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TORTUOUS AND CALCIFIED PERIPHERAL LOWER LIMB LESION. A HIGH-TORQUE ALLSTAR GUIDE WIRE WAS ADVANCED TO THE LESION WITH RESISTANCE FROM THE ANATOMY. A NON-ABBOTT RE-ENTRY CATHETER WAS ADVANCED OVER THE GUIDE WIRE TO TREAT THE LESION; HOWEVER, WAS ADVANCED TOO FAR OVER THE WIRE AND MET RESISTANCE WITH THE GUIDE WIRE TIP. THE TIP OF THE GUIDE WAS SUBINITIMAL [INTENTIONALLY] AT THE TIME AND WAS SHEERED OFF [SEPARATED]. AS THE TIP REMAINED SUBINTIMAL IN THE VESSEL WALL, NO ATTEMPTS TO RETRIEVE IT WERE PERFORMED. THE PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Vessel Or Plaque, Device Embedded In
MAUDE report 9107493 ↗
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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