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HiWire G30472Recalls & reported problems

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

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 00827002304727), received between Oct 6, 2022 and Oct 6, 2022 — classified as 1 malfunction.

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

Most reported problems

Device problems

  • Peeled/Delaminated1

Patient problems

  • Insufficient Information1
  • 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.

  • MalfunctionOct 6, 2022Peeled/Delaminated; Peeled/Delaminated

    ADDITIONAL INFORMATION RECEIVED 04NOV2022: THE USER FACILITY REPORTED THAT THE WIRE WAS NOT ALTERED FROM ITS ORIGINAL CONDITION PRIOR TO USE. BOTH POWDER AND LATEX GLOVES WERE WORN DURING DEVICE USE. THE DEVICE WAS USED ONE TIME. THE WIRE FLUSHED WITH SALINE PRIOR TO USE. THE USER WAS NOT AWARE OF ANY FLAKING ON THE WIRE. THE REPORTER IS UNSURE HOW THE COATING WAS ACTIVATED, HOW LONG THE COATING WAS ACTIVATED, OR IF THE COATING WAS REACTIVATED BEFORE REUSE. THE REPORTER STATED THEY ARE NOT AWARE OF ANY UNINTENDED SECTION OF THE DEVICE REMAINING INSIDE THE PATIENTS BODY, IF THE PATIENT WAS HOSPITALIZED OR HAD PROLONGED HOSPITALIZATION, IF THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, IF THERE WERE ANY ADVERSE EFFECTS ON THE PATIENT, OR IF THERE WERE ANY SURGICAL/MEDICAL INTERVENTIONS PERFORMED DUE TO THIS OCCURRENCE.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 15550029 ↗

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