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DuaLok™ LW0137Recalls & reported problems

Bard Peripheral Vascular, Inc. · DuaLok™ Breast Lesion Localization Wire, 20g x 13.7cm · Class 1 · Implant

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 00801741079764), received between Mar 19, 2022 and Mar 19, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1

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.

  • MalfunctionMar 19, 2022Break; Break

    IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY BROKE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13820137 ↗

Other GUIDE, NEEDLE, SURGICAL devices

All GUIDE, NEEDLE, SURGICAL devices →

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