DuaLok™ LW0107Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741079757), received between Aug 22, 2018 and Aug 27, 2026 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 22, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE WAS ALLEGEDLY FOUND WITH FOREIGN MATERIAL. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12850404 ↗
• MalfunctionApr 4, 2019Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT INVOLVING 2 DEVICES ON THE SAME PATIENT. A REVIEW OF THE EVENT INDICATED THAT MODEL LW0107 BREAST LOCALIZATION WIRE EXPERIENCED BOTH DIFFICULTY TO ADVANCE AND DIFFICULTY TO REMOVE ON BOTH DEVICES. THIS WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO REPORTED INJURY. THE PATIENT IS FEMALE, AND AGE AND WEIGHT WERE NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8485527 ↗
• InjuryAug 22, 2018Positioning Failure; Difficult to Remove; Difficult to Advance; Positioning Failure; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY INTO NORMAL TISSUE, THE DEVICE ALLEGEDLY FAILED TO DEPLOY AND WAS DIFFICULT TO REMOVE FROM THE PATIENT. A TEAR IN THE PATIENT'S TISSUE OCCURRED AS A RESULT OF THE REMOVAL OF THE DEVICE. IT WAS FURTHER REPORTED THAT A PLANNED SECONDARY INTERVENTION WAS PERFORMED AND ANOTHER DEVICE WAS USED TO COMPLETE THE BIOPSY. THE PATIENT IS STABLE.

  Patient problems: Excessive Tear Production

  MAUDE report 7807552 ↗