HI-TORQUE ADVANCE 1044586Recalls & reported problems
Abbott Vascular Inc. · HI-TORQUE ADVANCE LITE Guide Wire .014 Straight Tip 3.0 cm x 190 cm · Class 2
Data updated Oct 16, 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 08717648014468), received between Nov 24, 2020 and Nov 24, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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 16, 2026.
Most reported problems
Device problems
- 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.
MalfunctionNov 24, 2020Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.5X20MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED PER INSTRUCTIONS FOR USE AND WITH A 50/50 RATIO CONTRAST FOR POST-DILATATION. THE BDC WAS INFLATED TWO TIMES AT 14 ATMOSPHERES; HOWEVER, IT WAS NOTED THAT THE BALLOON DID NOT DEFLATE AFTER THE SECOND INFLATION. A NEGATIVE WAS HELD FOR 10 SECONDS, BUT THE BALLOON ONLY PARTIALLY DEFLATED. THE BDC BECAME CAUGHT ON THE NON-ABBOTT GUIDE WIRE. ALL DEVICES WERE REMOVED AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE GUIDE WIRE THAT BECAME CAUGHT IN THE BDC WAS AN ABBOTT VASCULAR HT ADVANCE LITE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10892314 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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