HI-TORQUE BALANCE HEAVYWEIGHT 1000463HRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE BALANCE HEAVYWEIGHT Guide Wire w/Hydrocoat .014 Straight 4.5 cm x 300 cm · Class 2
All models of HI-TORQUE BALANCE HEAVYWEIGHT (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648015502), received between Nov 24, 2020 and Dec 8, 2023 — classified as 1 injury, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove2
- Material Separation2
- Deformation Due to Compressive Stress1
- Difficult to Advance1
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.
InjuryDec 8, 2023Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance
IT WAS REPORTED THAT WAS TO TREAT THE LEFT UPPER PULMONARY VEIN. THE 014 BALANCE HEAVYWEIGHT HYDRO GUIDE WIRE WAS PLACED AND A BALLOON WAS ADVANCED OVER THE GUIDE WIRE; HOWEVER, SOME RESISTANCE WAS FELT AND WHEN REMOVING THE BALLOON RESISTANCE WAS FELT AGAIN WITH THE GUIDE WIRE. DURING REMOVAL OF THE GUIDE WIRE THROUGH THE CATHETER SOME RESISTANCE WAS NOTED AND UNDER FLUOROSCOPY THE TIP SEPARATED, THE SEPARATION PORTION WAS REMOVED VIA SNARE. ANOTHER 0.014 HEAVY WEIGHT WIRE WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18297651 ↗MalfunctionNov 24, 2020Difficult to Remove; Material Separation; Deformation Due to Compressive Stress; Difficult to Remove; Material Separation; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO INCREASE THE SIZE OF A CENTRAL SHUNT NEAR THE AORTA AND PULMONARY. A BALANCE HEAVYWEIGHT HYDRO GUIDE WIRE WAS ADVANCED WITH A NON-ABBOTT BALLOON. RESISTANCE WAS FELT BETWEEN THE GUIDE WIRE AND BALLOON DURING REMOVAL, AND THE PROXIMAL CORE OF THE GUIDE WIRE BECAME BENT. WHILE OUTSIDE THE ANATOMY, THE PROXIMAL CORE BECAME SEPARATED, AND THE SEPARATED PORTION WAS SIMPLY REMOVED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10891807 ↗
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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