HI-TORQUE FLOPPY 22359MRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE FLOPPY II Guide Wire .014 Straight Tip 2.0 cm x 300 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 08717648080319), received between Jul 25, 2018 and Dec 5, 2018 — 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 16, 2026.
Most reported problems
Device problems
- Difficult to Remove2
- Difficult to Advance1
- Improper or Incorrect Procedure or Method1
- Material Separation1
- Off-Label Use1
Patient problems
- Foreign Body In Patient1
- 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.
MalfunctionDec 5, 2018Off-Label Use; Difficult to Remove; Off-Label Use; Difficult to Remove
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEG. A HI-TORQUE FLOPPY II GUIDE WIRE WAS ADVANCED FOR AN ATHERECTOMY PROCEDURE. ON REMOVAL OF THE NON-ABBOTT ATHERECTOMY CATHETER RESISTANCE WAS MET WITH THE GUIDE WIRE. THE GUIDE WIRE AND ATHERECTOMY CATHETER WERE REMOVED TOGETHER AS A SINGLE UNIT. AN ADDITIONAL NON-ABBOTT GUIDE WIRE AND AN UNSPECIFIED BALLOON CATHETER WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8134502 ↗InjuryJul 25, 2018Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY TORTUOSITY, MODERATELY CALCIFIED RAMOUS CORONARY ARTERY. RESISTANCE WAS FELT WITH THE ANATOMY DURING ADVANCEMENT OF THE FLOPPY II EXCHANGE GUIDE WIRE. DURING REMOVAL, RESISTANCE WAS FELT AGAIN WITH THE ANATOMY. FORCE WAS USED DURING REMOVAL AND THE GUIDE WIRE TIP SEPARATED IN THE ANATOMY. A STENT WAS IMPLANTED EMBEDDING THE GUIDE WIRE TIP AGAINST THE VESSEL WALL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 7719874 ↗
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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