HI-TORQUE FLOPPY 22299HRecalls & reported problems
Abbott Vascular Inc. · HI-TORQUE FLOPPY II Extra Support Guide Wire with HYDROCOAT Hydrophilic Coating .014 Straight Tip 2.0 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648079658), received between Dec 23, 2019 and Dec 23, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
- Material Too Soft/Flexible1
Patient problems
- Intimal Dissection1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 23, 2019Material Separation; Material Too Soft/Flexible; Material Separation; Material Too Soft/Flexible
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE DIAGONAL BRANCH. A 014 HT FLOPPY II EXTRA SUPPORT GUIDE WIRE WAS ADVANCED THROUGH THE LESION AND PROLAPSED WHEN PASSING THROUGH AN ALREADY IMPLANTED UNSPECIFIED STENT. THE WIRE WAS ADVANCED DISTALLY TO THE DESIRED POSITION. AFTER COMPLETION OF THE INTERVENTION, PART OF THE GUIDE WIRE SEPARATED AND WAS LEFT IN THE PATIENT. THIS RESULTED IN A DISSECTION AND THE PATIENT HAD A PERICARDIAL EFFUSION. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND THERE THE DISSECTION WAS TREATED WITH AORTO-CORONARY-BYPASS. MAJOR SURGERY WAS PERFORMED TO SUCCESSFULLY TREAT THE PERICARDIAL EFFUSION AND TO RETRIEVE THE SEPARATED GUIDE WIRE PIECE. THE PATIENT IS STABLE. THERE WAS CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Intimal Dissection; Pericardial Effusion
MAUDE report 9513640 ↗
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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