HI-TORQUE FLOPPY 22359M-901Recalls & reported problems
Abbott Vascular Inc. · HI-TORQUE FLOPPY II EXTRA SUPPORT GuideWire .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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648080326), received between Mar 30, 2017 and Jul 14, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment Of Device Component” (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
- Detachment Of Device Component1
- Difficult to Remove1
- Material Separation1
- Physical Resistance1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 14, 2022Material Separation; Material Separation
USER FACILITY MEDWATCH RECEIVED WHICH STATES: ABBOTT HI TORQUE FLOPPY EXTRA SUPPORT 0.14X30CM. FDA SAFETY REPORT ID# (B)(4). THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE ACCOUNT: THE PROCEDURE WAS AN IMPELLA ASSISTED PERCUTANEOUS CORONARY INTERVENTION AND THE HI TORQUE EXTRA SUPPORT GUIDE WIRE TIP FRACTURED IN THE DISTAL RAMUS BRANCH AND NO ATTEMPTS WERE REPORTED TO REMOVE THE TIP. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. THE PATIENT WAS DISCHARGED TO HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 15015519 ↗InjuryMar 30, 2017Detachment Of Device Component; Difficult to Remove; Physical Resistance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SECOND OBTUSE MARGINAL BRANCH. RESISTANCE WAS FELT DURING ADVANCEMENT OF THE HT FLOPPY II GUIDE WIRE TO THE LESION. WHEN THE GUIDE WIRE WAS RETRACTED IN A BACKWARD MOTION DURING THE ATTEMPT TO CROSS, RESISTANCE WAS FELT AND THE GUIDE WIRE TIP SEPARATION OCCURRED. THE TIP REMAINED IN THE DISTAL SECOND OBTUSE MARGINAL BRANCH AND WAS UNABLE TO BE RETRIEVED AFTER MULTIPLE SNARING ATTEMPTS. THE PROCEDURE WAS ABORTED DUE TO THE LENGTH OF TIME THAT THE PATIENT REMAINED ON THE OPERATING TABLE. SURGICAL REMOVAL OF THE TIP WAS NOT PERFORMED. THE PATIENT WAS PRESCRIBED PLAVIX AND DISCHARGED FROM THE HOSPITAL. IT WAS STATED THAT THE GUIDE WIRE CROSSED THE LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 6446868 ↗
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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