HI-TORQUE BALANCE MIDDLEWEIGHT™ 1011882Recalls & reported problems
Abbott Vascular Inc. · HT BALANCE MIDDLEWEIGHT ELITE™ Guide Wire .014" 3 cm Straight Tip 190 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 08717648144820), received between Nov 28, 2022 and Nov 28, 2022 — 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
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 28, 2022Peeled/Delaminated; Difficult to Remove; Difficult to Advance; Peeled/Delaminated; Difficult to Remove; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA). A 014 HT BMW ELITE GUIDE WIRE (GW) WAS BEING ADVANCED THROUGH THE GUIDE CATHETER WHEN RESISTANCE WAS FELT BETWEEN THE GUIDE WIRE AND THE GUIDE CATHETER. THE GUIDE WIRE WAS REMOVED AND ONCE OUTSIDE THE PATIENT ANATOMY, SEGMENTS OF THE GUIDE WIRE FELT AND LOOKED LIKE IT HAD BEEN SHAVED. IMAGING SHOWED NO GUIDE WIRE COATING IN THE ANATOMY AND NO FOREIGN MATERIAL WAS REMOVED FROM THE PATIENT. A NEW BMW GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15874928 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page