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Bentson G14590Recalls & reported problems

Cook Incorporated · Bentson PTFE Wire Guide With 15cm Flexible Tip · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002145900), received between Feb 8, 2017 and Feb 8, 2017 — classified as 1 injury.

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

  • Material Frayed1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 8, 2017Material Frayed; Material Frayed

    IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT AN URETEROSCOPY PROCEDURE USING AN STANDARD FIXED CORE WIRE GUIDE. THE ATTENDING PHYSICIAN INDICATED THAT WHILE PERFORMING THIS PROCEDURE THE WIRE FRAYED. A PIECE OF THE WIRE HAD TO BE RETRIEVED FROM THE PATIENT. NO UNINTENDED SECTIONS OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY NOR DID THE PATIENT EXPERIENCE ANY ADDITIONAL PROCEDURES OR ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6312059 ↗

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