DuaLok™ LW0077Recalls & reported problems
Bard Peripheral Vascular, Inc. · DuaLok™ Breast Lesion Localization Wire, 20g x 7.7cm · Class 1 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741079740), received between Jun 5, 2017 and Jul 27, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break3
- Difficult to Remove2
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Break; Material Twisted/Bent
On (b)(6) 2026, a patient underwent an ultrasound guided breast mass tissue localization wire placement procedure using a DuaLok Localization Wire. During the procedure, it was noticed that guidewire breakage. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50020954 ↗MalfunctionNov 7, 2023Break; Break
IT WAS REPORTED THAT DURING A LUNG BIOPSY PROCEDURE, THE CLAW AT THE FRONT END OF THE POSITIONING NEEDLE WAS ALLEGEDLY BROKEN IN THE LUNG AND THE BROKEN PART WAS FOUND AFTER THE LUNG TISSUE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18082105 ↗MalfunctionAug 2, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, THE CATHETER WAS ALLEGEDLY GOT STUCK WHEN PULLING OUT. IT WAS FURTHER REPORTED THAT IT WAS ALLEGEDLY DIFFICULT TO REMOVE THE CANNULA FROM THE GUIDEWIRE AFTER POSITIONING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17445896 ↗MalfunctionAug 2, 2023Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, THE CATHETER WAS ALLEGEDLY GOT STUCK WHEN PULLING OUT. IT WAS FURTHER REPORTED THAT IT WAS ALLEGEDLY DIFFICULT TO REMOVE THE CANNULA FROM THE GUIDEWIRE AFTER POSITIONING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17440915 ↗MalfunctionJun 5, 2017Break; Break
IT WAS REPORTED THAT DURING A BREAST TISSUE LOCALIZATION WIRE PLACEMENT, THE CANNULA ALLEGEDLY BROKE FROM THE PLASTIC HUB. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6613190 ↗
Other GUIDE, NEEDLE, SURGICAL devices
- GHIATAS® 47920Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL20 reports
- DuaLok™ LW0107Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL11 reports
- GHIATAS® 47720Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL7 reports
- GHIATAS® 477201Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL7 reports
- PERL Localization Device R2020Focal Therapeutics, Inc. · Guide, Needle, Surgical7 reports
- GHIATAS® 475201Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL6 reports
- GHIATAS® 479201Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL5 reports
- DuaLok™ LW0057Bard Peripheral Vascular, Inc. · GUIDE, NEEDLE, SURGICAL3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.