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HiWire G30477Recalls & reported problems

Cook Incorporated · HiWire Nitinol Core Wire Guide Straight with Hydrophilic Coating Stiff Shaft and 3cm Flexible Tip · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002304772), received between Nov 19, 2020 and Feb 14, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Peeled/Delaminated2

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1
  • No Information1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 14, 2022Peeled/Delaminated; Peeled/Delaminated

    AS REPORTED, DURING A VARICOSE VEIN CLOSURE PROCEDURE, A HIWIRE NITINOL HYDROPHILIC WIRE GUIDE BECAME "COMPLETELY SOFT, FLACCID." THE DEVICE WAS USED TO INTRODUCE A CLOSURE CATHETER, BUT WHEN THE DEVICE WAS ATTEMPTED TO BE REMOVED, IT BECAME STUCK IN THE CATHETER. THE DEVICE AND "METALLIC AND COATING PIECES" WERE SUCCESSFULLY REMOVED FROM THE PATIENT, THOUGH IT IS UNKNOWN HOW THEY WERE REMOVED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13524112 ↗
  • MalfunctionNov 19, 2020Peeled/Delaminated; Peeled/Delaminated

    THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Patient problems: Insufficient Information; No Information

    MAUDE report 10867779 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.