HI-TORQUE STEELCORE 1007710-JRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE STEELCORE 18 LT Peripheral Guide Wire J Tip 300 cm · Class 2
All models of HI-TORQUE STEELCORE (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648049347), received between Mar 31, 2021 and Apr 1, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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 18, 2026.
Most reported problems
Device problems
- Difficult to Remove2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2021Difficult to Remove; Difficult to Remove
MalfunctionMar 31, 2021Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE LEFT SUPERFICIAL FEMORAL ARTERY, HEAVILY CALCIFIED LESION. A SUPERA STENT WAS SUCCESSFULLY IMPLANTED. A SECOND SUPERA STENT (S-60-040-120-P6, 0050461) WAS ALSO DEPLOYED SUCCESSFULLY. WHILE REMOVING THE SECOND SUPERA DELIVERY SYSTEM HOWEVER, RESISTANCE WAS MET BETWEEN THE SECOND SUPERA DELIVERY SYSTEM AND THE STEELCORE GUIDE WIRE (1007710-J, 0080761). THE GUIDE WIRE AND SUPERA DELIVERY SYSTEM WERE REMOVED WITHOUT FURTHER ISSUES AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT, NO INTERVENTION OR TREATMENT REQUIRED, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11599679 ↗
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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