HiWire G36300Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002363007), received between Jul 11, 2016 and Sep 18, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Appropriate Device Problem Term/Code Not Available1
- Material Fragmentation1
- Peeled/Delaminated1
Patient problems
- Dyspnea1
- No Known Impact Or Consequence To Patient1
- Pneumonia1
- Sepsis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2018Peeled/Delaminated
IT WAS REPORTED THAT DURING THE PROCEDURE, THE WIRE GUIDES LOST THEIR HYDROPHILIC COATING. THE COATING WAS SWELLING. THERE WERE NO ADVERSE EFFECTS AND ADDITIONAL PROCEDURES REPORTED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7885856 ↗InjuryJul 11, 2016Material Fragmentation; Appropriate Device Problem Term/Code Not Available; Material Fragmentation; Appropriate Device Problem Term/Code Not Available
THE PATIENT HAD AN INTERVENTIONAL RADIOLOGY PROCEDURE DONE ON (B)(6) 2015 INVOLVING 2 BEACON TIP CATHETERS AND A HIWIRE HYDROPHILIC WIRE GUIDE. IN 2016, THE PATIENT WAS AT ANOTHER FACILITY FOR A CHEST X-RAY WHEN IT WAS NOTED THAT TWO PIECES OF THE WIRE GUIDE HAD FRACTURED AND REMAINED IN THE PATIENT. ON (B)(6) 2016, THE FRAGMENTED PIECES WERE REMOVED WITH A SNARE PERCUTANEOUSLY AND DID NOT REQUIRE A CUTDOWN INCISION. THE PATIENT IS DOING VERY WELL. EVENT AS LISTED ON MEDWATCH. " (B)(6) ADMITTED TO ANGIO SUITE AT @0900 WITH PRE-OP SX. OF CRITICAL STENOSIS. UNDER MAC, PATIENT UNDERWENT PERCUTANEOUS PROCEDURES AS FOLLOWS: TRANSFERRED TO PACU IN STABLE CONDITION. DISCHARGED HOME ON (B)(6) 2015. ON (B)(6) 2016: PATIENT PRESENTS TO AREA HOSPITAL WITH THREE DAY HISTORY OF COUGHING, FEVER DYSPNEA, VOMITING AND MALAISE. PATIENT IS "SEPTIC, APPEARS TO HAVE PNEUMONIA". INCIDENTAL FINDING OF RETAINED FOREIGN BODY (GUIDEWIRE) NOTED IN THORACIC AORTA EXTENDING UP FROM THE LEFT GROIN AND TERMINATING IN THE AORTIC ARCH. IMPRESSION: RETAINED FOREIGN BODY ". THE FRAGMENTED PIECES WERE REMOVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENC
Patient problems: Dyspnea; Pneumonia; Sepsis
MAUDE report 5782776 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page