HI-TORQUE ALL STAR 1001741JRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE ALL STAR Guide Wire .014 J Tip 3.0 cm x 300 cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648025952), received between Sep 5, 2019 and Dec 6, 2021 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (3 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 18, 2026.
Most reported problems
Device problems
- Material Separation3
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2021Material Separation; Material Separation
IT WAS REPORTED THAT THE 014 ALLSTAR GUIDE WIRE SHAFT WAS WIPED WITH A STERILE GAUZE BEFORE ADVANCING IN THE ANATOMY AND WIRE FRAGMENTS WERE NOTED ON THE GAUZE. THE COILS SEPARATED FROM THE WIRE. ANOTHER UNSPECIFIED GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12933738 ↗InjurySep 5, 2019Material Separation; Material Separation
USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: "WHEN PULLING BACK A GUIDEWIRE THRU THE OUTBACK ELITE RE-ENTRY CATHETER THE WIRE WAS SEVERED ON TWO DIFFERENT OCCASIONS WITH TWO SEPARATE WIRES (ABBOTT .014 ALLSTAR WIRES). WIRE FRAGMENTS WERE RETRIEVED. UNCERTAIN IF MALFUNCTION OF DEVICE OR EXTENSIVE CALCIFICATION. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? AABLE AND PTA/STENT LEFT COMMON ILIAC ARTERY, ATTEMPTED PTA R ILIAC ARTERY. WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8967871 ↗InjurySep 5, 2019Material Separation; Material Separation
USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: "WHEN PULLING BACK A GUIDEWIRE THRU THE OUTBACK ELITE RE-ENTRY CATHETER THE WIRE WAS SEVERED ON TWO DIFFERENT OCCASIONS WITH TWO SEPARATE WIRES (ABBOTT .014 ALLSTAR WIRES). WIRE FRAGMENTS WERE RETRIEVED. UNCERTAIN IF MALFUNCTION OF DEVICE OR EXTENSIVE CALCIFICATION. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? ABLE AND PTA/STENT LEFT COMMON ILIAC ARTERY, ATTEMPTED PTA R ILIAC ARTERY. WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8967824 ↗
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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