DuaLokRecalls & reported problems across all models

We found 4 models of DuaLok by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2017 and Aug 27, 2026 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported DuaLok problems

DuaLok models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DuaLok™ LW0107

  GUIDE, NEEDLE, SURGICAL
  11 reports
• DuaLok™ LW0077

  GUIDE, NEEDLE, SURGICAL
  5 reports
• DuaLok™ LW0057

  GUIDE, NEEDLE, SURGICAL
  3 reports
• DuaLok™ LW0137

  GUIDE, NEEDLE, SURGICAL
  1 report

Recent DuaLok adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Break

  On (b)(6) 2026, a patient underwent an X ray guided breast localization wire procedure using the DuaLok Localization Wire. During the procedure the device Guidewire was broken. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479615 ↗
• 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 ↗
• InjuryMar 5, 2026Break; Difficult to Remove

  ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST LOCALIZATION WIRE PROCEDURE USING THE DUALOK WIRE. DURING THE PROCEDURE, THE DEVICE WIRE WAS BROKEN AND DIFFICULT TO REMOVE THE WIRE FROM THE PATIENT. THERE WAS REPORTED PATIENT INJURY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24517062 ↗
• MalfunctionJan 9, 2026Break

  ON (B)(6) 2025, A PATIENT UNDERWENT A ULTRASOUND GUIDE PATIENT UNDERWENT A BREAST TISSUE LOCALIZATION PROCEDURE VIA NORMAL DENSITY TISSUE BY USING THE DUALOCK LOCALISATION WIRE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE WIRE ALLEGEDLY BROKE CLEANLY IN TWO. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016866 ↗
• MalfunctionNov 27, 2025Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  ON (B)(6) 2025, A PATIENT UNDERWENT MAMMOGRAM BIOPSY PROCEDURE USING DUALOK WIRE. POST THE PROCEDURE, THE MAMMOGRAM SHOWED THE HOOK WAS SNAPPED INTO TWO. IT WAS FURTHER REPORTED THAT DURING DEPLOYMENT UNDER US DUALOK, IT WAS DIFFICULT TO BE SEEN, HENCE SNAPPING WAS NOT NOTICEABLE. NO COAXIAL NEEDLE WAS USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665059 ↗
• InjuryAug 26, 2024Break; Migration; Break; Migration

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED LOCALIZATION WIRE PLACEMENT PROCEDURE, THE WIRE HAD TO BE REPOSITIONED AND RE-SHEATHED. IT WAS FURTHER REPORTED THAT AT THE TIME OF PERFORMING MAMMOGRAPHY FOR ITS VERIFICATION, ONE OF ITS HOOKS WAS ALLEGEDLY BROKEN, MOVING AND NOT BEING ABLE TO STAY SECURELY IN THE BREAST. FURTHERMORE, AS IT WAS ALREADY IN POSITION IN THE BREAST, THE PHYSICIAN DECIDED TO LEAVE IT IN POSITION FIXED ON THE OUTSIDE WITH MESH AND PATCHES. REPORTEDLY, SURGICAL INTERVENTION WAS PERFORMED TO REMOVE THE BROKEN FRAGMENTS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20063412 ↗
• MalfunctionFeb 15, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD LABELLING PROBLEM, AS THE LABEL HAS THE RIGHT INDICATION BUT THE REST OF THE PACKAGING HAD DIFFERENT PRODUCT DESCRIPTION. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18709290 ↗
• MalfunctionFeb 15, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD LABELLING PROBLEM, AS THE LABEL HAS THE RIGHT INDICATION BUT THE REST OF THE PACKAGING HAD DIFFERENT PRODUCT DESCRIPTION. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18709253 ↗
• MalfunctionDec 14, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE WIRE WAS ALLEGEDLY FRACTURED AT THE SKIN SURFACE AND THERE WAS NO UNDUE MOVEMENT OF FORCE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325323 ↗
• MalfunctionNov 13, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD LABELLING PROBLEM, AS THE LABEL HAS THE RIGHT INDICATION BUT THE REST OF THE PACKAGING HAD DIFFERENT PRODUCT DESCRIPTION. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117809 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 19, 2021Improper or Incorrect Procedure or Method; Device Markings/Labelling Problem; Improper or Incorrect Procedure or Method; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A MRI GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY MISLABELED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13041083 ↗

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