Brevera Breast Biopsy System BREV09Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15420045507777), received between Apr 3, 2020 and May 27, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K163052); they may or may not involve this specific model.

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.

• MalfunctionMay 27, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING RETRACTING THE BIOPSY NEEDLE THE SLEEVE OF THE INTRODUCER DISTORTED AND A HOLE WAS NOTED IN THE SLEEVE. NO INJURY REPORTED. THE USER SUCCEEDED IN PLACING THE NEEDLE AND THE MARKER IN THE AREA THAT WAS BIOPSIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893407 ↗
• InjuryMar 30, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE EQUIPMENT AND NEEDLE WERE SET UP AND TESTED CORRECTLY. AFTER TAKING 6 TISSUE SAMPLES THERE WERE NO CALCIFICATIONS VISIBLE. AFTER TAKING 18 TISSUE SAMPLES, ONLY 8 VERY SMALL SAMPLES WERE AVAILABLE. IT WAS UNKNOWN IF THE SAMPLES WOULD BE SUFFICIENT FOR DIAGNOSIS. ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER CONFIRMED THAT THE PATIENT WILL NEED TO UNDERGO ANOTHER BIOPSY DUE TO INSUFFICIENT TISSUE SAMPLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11591287 ↗
• MalfunctionApr 27, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE ON (B)(6) 2020 THE BREVERA SHEATH BEGAN TO TWIST AND CRUMPLE WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE NEEDLE FROM THE BIOPSY SITE. THERE WAS NO IMPACT OR HARM REPORTED TO THE PATIENT. NO ADDITIONAL DETAILS AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10002772 ↗
• MalfunctionApr 3, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE, "WHEN THE NEEDLE WAS DIALED DOWN INTO THE BREAST THE SHEATH WOULD SCRUNCH UP." NO KNOWN IMPACT TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9924261 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163052. One submission often covers many models, so check the product and lot details in each record.

• Z-1314-2026 · Dec 15, 2025 · Open, Classified
  Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.