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Bentson G14589Recalls & reported problems

Cook Incorporated · Bentson PTFE Wire Guide With 15cm 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 00827002145894), received between Sep 7, 2022 and Sep 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unraveled Material” (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

  • Unraveled Material1

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.

  • MalfunctionSep 7, 2022Unraveled Material; Unraveled Material

    AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE WIRE FROM A STANDARD FIXED CORE WIRE GUIDE UNRAVELED INSIDE THE PATIENT. THE DEVICE DID NOT SEPARATE, AND NO PORTION OF THE DEVICE WAS LEFT IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, BUT DETAILS HAVE NOT BEEN CONFIRMED ON HOW IT WAS COMPLETED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15370068 ↗

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