HiWire G36293Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002362932), received between Mar 15, 2019 and Jul 31, 2023 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Flaked” (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
- Flaked2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Peeled/Delaminated1
Patient problems
- No Code Available2
- Blood Loss1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- Perforation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2023Flaked; Flaked
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17425576 ↗MalfunctionAug 21, 2019Flaked; Peeled/Delaminated; Flaked; Peeled/Delaminated
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8916170 ↗InjuryMar 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. THIS INFORMATION IS DETAILED IN SECTION H10.
Patient problems: Blood Loss; No Code Available; Perforation
MAUDE report 8425804 ↗MalfunctionMar 15, 2019Break
PATIENT HAD A LEFT EXTERNAL ILIAC ARTERY STENT PLACE. AFTER POST DILATATION OF THE STENT A PERFORATION OF THE LEFT EXTERNAL ILIAC ARTERY WAS NOTED. A BALLOON THEN WAS INSERTED AND INFLATED IN THE VESSEL FOR APPROXIMATELY 2 MINS. THE BALLOON WAS DEFLATED AND DURING THE REMOVAL OF THE BALLOON THE SHAFT BROKE ONTO THE WIRE. IT REQUIRED A ADDITIONAL 10-15MINS TO REMOVE THE BROKEN SHAFT. IN THE MEANTIME THE PATIENT WAS STARTED ON DOPAMINE AND NOREPINEPHRINE VASOPRESSORS AS WELL AS 2 UNITS PRBCS. A COVER STENT WAS EVENTUALLY INSERTED TO SEAL OFF THE PERFORATION.
Patient problems: No Code Available
MAUDE report 8424111 ↗
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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