HiWire G36284Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002362840), received between Mar 1, 2023 and Mar 1, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Perforation” (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 Perforation1
- Material Protrusion/Extrusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 1, 2023Material Perforation; Material Protrusion/Extrusion; Material Perforation; Material Protrusion/Extrusion
AS REPORTED, DURING A PROCEDURE INVOLVING EMBOLIZATION OF THE UTERINE ARTERY VIA ACCESS IN THE RIGHT GROIN, A HIWIRE HYDROPHILIC WIRE GUIDE'S INNER CORE WIRE PERFORATED THE WIRE JACKET AND AN UNSPECIFIED "RBT" CATHETER DURING INITIAL USE OF THE DEVICE. THE ANATOMY WAS NOT TORTUOUS, CALCIFIED, OR SCARRED. THE WIRE WAS NOT ALTERED PRIOR TO USE. NON-LATEX, NON-POWDERED GLOVES WERE WORN DURING THE PROCEDURE, AND THE HYDROPHILIC COATING WAS ACTIVATED WITH HEPARINIZED SALINE ONE TIME. AT THE END OF THE PROCEDURE, AS THE USER ATTEMPTED TO TURN THE WIRE AT THE CATHETER ANGLE, THE CORE WIRE PUNCTURED THROUGH THE WIRE JACKET AND CATHETER MATERIAL. THE WIRE DID NOT PERFORATE THE VESSEL AND THE PATIENT WAS NOT HARMED. THERE HAS BEEN NO REPORT THAT THE COATING FLAKED FROM THE DEVICE. ALTHOUGH THE PROCEDURE WAS REPORTEDLY NOT COMPLETED SUCCESSFULLY, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT. NOTHING REMAINED IN THE PATIENT'S BODY AND THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16463243 ↗
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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