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BiWire G46139Recalls & reported problems

Cook Incorporated · BiWire Nitinol Core Wire Guide With Hydrophilic Coating Stiff Shaft · 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 00827002461390), received between Jun 23, 2022 and Jun 23, 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

  • 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.

  • MalfunctionJun 23, 2022Peeled/Delaminated; Peeled/Delaminated

    AS REPORTED, DURING A DEVICE PREOPERATIVE EXAMINATION, IT WAS DISCOVERED THAT THE COATING ON A BIWIRE NITINOL HYDROPHILIC WIRE GUIDE WAS HAD FALLEN OFF AT THE "SHEATH END." A NEW WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14786748 ↗

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