HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL 1009661JRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire .014 J Tip 3.0 cm x 300 cm · Class 2
All models of HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL (4)
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 08717648065873), received between Aug 20, 2019 and Apr 10, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Difficult to Remove1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2023Break; Break
IT WAS REPORTED THAT DURING OPENING OF THE PACKAGE, THE HT-BMW UNIVERSAL GUIDE WIRE WAS REMOVED FROM THE HOOP AND THE TIP WAS NOTED TO BE BROKEN [APPEARS TO BE IN ONE PIECE]. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16708318 ↗MalfunctionAug 20, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CIRCUMFLEX CORONARY ARTERY. ON REMOVAL OF A HI-TORQUE BALANCE MIDDLE WEIGHT UNIVERSAL GUIDE WIRE WITHOUT FORCE, UNSPECIFIED RESISTANCE WAS MET AND THE TIP OF THE GUIDE WIRE SEPARATED. THE GUIDE WIRE TIP WAS CONTAINED WITHIN THE UNSPECIFIED GUIDING CATHETER AND WAS THEREFORE SIMPLY MANUALLY REMOVED WITH THE GUIDING CATHETER AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8913407 ↗
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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