Breast Localization Needles BLN20075Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886333007493), received between Jan 7, 2022 and Dec 1, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2023Failure to Align; Failure to Align

  DURING USE OF THE BLN PRODUCT, THE REINFORCED PART OF THE HOOK WIRE WAS NOT FIXED AND WAS PUSHED BACK AND COULDN¿T BE USED, SO THE SURGERY WAS PROCEEDED WITH ANOTHER PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253161 ↗
• MalfunctionNov 13, 2023Ejection Problem; Ejection Problem

  FOLLOWING THE PLACEMENT OF A SIMPLE HARPOON UNDER ULTRASOUND CONTROL AT THE LEVEL OF THE QSE LESION, THE LATTER MIGRATED INSIDE THE BREAST OF MRS. (B)(6). THE MAMMOGRAPHY IMAGE THEN TAKEN SHOWED US THAT THE HARPOON HAD MIGRATED WITH A PROXIMAL END AT THE LEVEL OF THE QSE AND A DISTAL END IN THE PRE-PECTORAL AREA. A SECOND DOUBLE J HARPOON WAS THEN PLACED. GOOD POSITIONING ON THE CONTROL SHOTS. THE GYNECOLOGIST MANAGED TO REMOVE THE DEFECTIVE HARPOON FROM THE PATIENT'S BREAST. IT TURNS OUT THAT IT IS DEFECTIVE: NO HOOK OR THE HOOK HAS NOT DEPLOYED.

  Patient problems: Insufficient Information

  MAUDE report 18122536 ↗
• MalfunctionApr 19, 2022Detachment of Device or Device Component

  ON (B)(6) 2019, THE PATIENT UNDERWENT PERCUTANEOUS PUNCTURE AND LOCALIZATION OF LEFT BREAST MASS WITH A POSITIONING NEEDLE UNDER ULTRASOUND GUIDANCE. THE PURPOSE OF USE IS TO LOCATE BREAST NODULES. THE RESIDUAL METAL FOREIGN BODY FOUND IN THE RE-EXAMINATION IS SUSPECTED TO BE PART OF THE STRUCTURE OF THE POSITIONING NEEDLE. THE PATIENT WAS OPERATED ON AND REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14139500 ↗
• MalfunctionJan 7, 2022Activation, Positioning or Separation Problem

  AFTER THE PROCEDURE, THEY FOUND THAT THE HARD WIRE PART WAS PUSHED BACK AS ATTACHED PIC. AND WE WERE ASKED BY THE HOSPITAL TO CHECK WITH THE MANUFACTURER.

  Patient problems: Insufficient Information

  MAUDE report 13192610 ↗