HI-TORQUE FLOPPY 22339MJRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE FLOPPY II Guide Wire .014 J Tip 2.0 cm x 190 cm · Class 2
Data updated Oct 16, 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 08717648080135), received between Aug 13, 2022 and Dec 4, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Difficult to Advance1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 4, 2024Material Separation; Difficult to Advance; Material Separation; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH 90-95% STENOSIS, MODERATE CALCIFICATION AND MILD TORTUOSITY. THE HI-TORQUE (HT) FLOPPY II GUIDE WIRE HAD RESISTANCE DURING ADVANCEMENT WITH THE CALCIUM BUT REACHED THE TARGET LESION AND SEPARATED INTO TWO PIECES. A SNARE DEVICE WAS USED TO REMOVE THE SEPARATED PORTION. THERE WAS NO ADVERSE PATIENT SEQUELAE. ANOTHER NON-ABBOTT GUIDE WIRE WAS EXCHANGED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20845111 ↗MalfunctionAug 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE HI TORQUE FLOPPY GUIDE WIRE WAS NOTED TO BE RUSTY IN THE PACKAGE. THE PACKAGE WAS SEALED. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER HI TORQUE FLOPPY GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15222648 ↗
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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