HI-TORQUE BALANCE MIDDLEWEIGHT™ 1011883Recalls & reported problems
Abbott Vascular Inc. · HT BALANCE MIDDLEWEIGHT ELITE™ Guide Wire .014" 3 cm Straight Tip 300 cm w/o marker · Class 2
All models of HI-TORQUE BALANCE MIDDLEWEIGHT (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648144844), received between Feb 4, 2019 and Feb 4, 2019 — classified as 1 malfunction.
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
- Difficult to Remove1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2019Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND MILDLY CALCIFIED UNSPECIFIED CORONARY ARTERY. A 3.0 X 28 MM XIENCE PROX STENT DELIVERY SYSTEM (SDS) AND AN UNSPECIFIED BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WERE USED. HOWEVER, DURING ADVANCEMENT, THE SDS BECAME STUCK WITH THE GUIDE WIRE AND WAS NOT ABLE TO ADVANCE TOWARDS THE LESION. THEREFORE, BOTH DEVICES WERE REMOVED AS A SINGLE UNIT, AND THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRE. ANOTHER UNSPECIFIED DEVICE WAS THEN USED WITH A DIFFERENT UNSPECIFIED GUIDE WIRE 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 8302561 ↗
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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