HiWire G36292Recalls & reported problems
Cook Incorporated · HiWire Hydrophilic Wire Guide · Class 2
All models of HiWire (16)
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 00827002362925), received between Aug 28, 2017 and Aug 31, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2020Material Separation; Material Separation
ADDITIONAL INFORMATION RECEIVED 18SEP2020: AS THE WIRE WAS BEING REMOVED FROM THE NEEDLE IT SEPARATED WITHIN THE INTERNAL JUGULAR.
Patient problems: Foreign Body In Patient
MAUDE report 10471727 ↗InjuryAug 28, 2017Break; Break
A HIWIRE HYDROPHILIC WIRE GUIDE WAS USED IN A LEG ANGIOGRAM. IT WAS REPORTED, THE WIRE GUIDE WAS IN THE COMMON FEMORAL ARTERY, PLACED THROUGH THE SHEATH, UP AND OVER THE AORTA BIFURCATION. THE PATIENT'S ILIAC WAS CALCIFIED AND WHEN TRYING TO MANEUVER THE WIRE THE TIP SHEARED OFF COMPLETELY. THEY WERE ABLE TO GET THE TIP INTO THE CATHETER AND IT WAS REMOVED FROM THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 6824469 ↗
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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