Brevera Breast Biopsy System BREV200Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 15420045507753), received between Jun 9, 2022 and Dec 29, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE USER REPORTS THAT THE DEVICE WAS NOT INITIALLY OBTAINING ANY TISSUE SAMPLES WHEN THE NEEDLE WAS IN THE PATIENT'S BREAST. THE USER FURTHER REPORTS THAT THE NEEDLE WAS REPLACED, NEEDLE TESTS WERE PERFORMED, BUT WHEN THE NEEDLE WAS INSERTED INTO THE PATIENT, A DEVICE DRIVER ERROR WAS DISPLAYED. THE USER COMPLETED THE PROCEDURE USING ANOTHER DEVICE. A FIELD SERVICE ENGINEER WAS DISPATCHED TO EXAMINE THE DEVICE AND REPORTS, "DRIVER ISSUE WHEN USING ON PATIENT, CUSTOMER FOUND DEBRIS INSIDE NEEDLE." THE FSE WAS UNABLE TO DETERMINE IF THE DISPOSABLE NEEDLE OR THE DRIVER WAS THE CAUSE OF THE DEVICE ERROR; THEREFORE, THE DRIVER WAS REPLACED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23916791 ↗
• InjuryOct 27, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED BY THE USER SITE THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, AN ISSUE OCCURRED IN WHICH THE DEVICE INDICATED THAT THE FILTER WAS NOT RECOGNIZED DESPITE THE DEVICE SUCCESSFULLY PASSING PRE-PROCEDURE TESTING. IT IS REPORTED THAT THE NEEDLE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS ABORTED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE AND DETERMINED THAT THE CORLUMINA NEEDED TO BE REPLACED. THE FSE REPLACED THE CORLUMINA, COMPLETED REQUIRED CALIBRATIONS AND CONFIRMED THAT THE DEVICE IS FUNCTIONING. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393913 ↗
• InjuryJan 19, 2024Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON DECEMBER 27TH A BIOPSY PROCEDURE WAS PERFORMED WITH A BREVERA SYSTEM AND THE PHYSICIAN FEEL THAT THE VACUUM ON THE BREVERA SYSTEM WAS NOT WORKING PROPERLY AND AS EXPECTED. DESPITE PRECISE NEEDLE POSITIONING, THEY DID NOT GET ANY CALCIFICATIONS AND THE PATIENT HAD TO BE RESCHEDULED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18546138 ↗
• MalfunctionMay 19, 2023Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING A BREVERA PROCEDURE WHILE THE NEEDLE WAS INSIDE THE PATIENT´S BREAST, THE CONSOLE EXPERIENCED ISSUES WITH THE DRIVER THUS THEY HAD TO REBOOT THE CONSOLED AND COULD NOT OBTAIN THE SAMPLES. DUE TO THIS THE PROCEDURE WAS RESCHEDULED. THE EQUIPMENT WAS EXAMINED AND ISSUES WITH THE COMMUNICATION SOFTWARE WERE FOUND. THE SYSTEM IS SCHEDULED FOR SOFTWARE MAINTENANCE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962003 ↗
• InjuryOct 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON FRIDAY AFTERNOON THEY HAD A STEREO TO DO ON THE BREVERA. WHEN THE NURSE WENT TO PUT THE SPECIMEN IN THE PATH CONTAINER THERE WAS NO TISSUE IN THE 12-CHAMBER TISSUE FILTER. THEY RESET UP WITH ALL NEW KIT AND TOOK ANOTHER SAMPLE, AGAIN THERE WAS NO TISSUE SAMPLE. NO ERROR CODES OR MESSAGES ARE DISPLAYED ON THE UNIT. THE INVOLVED NEEDLES WERE CUT FROM THEIR TUBING AND DISPOSED OF. NO INJURY, BUT THE PATIENT HAS BEEN RESCHEDULED FOR ANOTHER BIOPSY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15562077 ↗
• MalfunctionOct 6, 2022Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREVERA BIOPSY PROCEDURE ON (B)(6) 2022. THE BREVERA CONSOLE AND THE DISPOSABLE WERE ALL SUCCESSFULLY TESTED. THE NEEDLE WAS THEN INSERTED INTO THE PATIENT BREAST AT THE TARGET, BUT AN ERROR MESSAGE (DEVICE DRIVER LOSS COMMUNICATION) WAS DISPLAYED ON THE CONSOLE; THEREFORE THE BIOPSY WOULD NOT START. THE NEEDLE WAS REMOVED, THE UNIT WAS REBOOTED BUT THIS COULD NOT SOLVE THE ISSUE. THE PROCEDURE WITH BREVERA SYSTEM WAS THEN ABANDONED. THE MEDICAL TEAM DECIDED TO USE ANOTHER METHOD: THE PATIENT WAS REMOVED FROM COMPRESSION, REPOSITIONED AND A NEW TARGET ACQUIRED; A SECOND INCISION WAS MADE AND THE BIOPSY WAS COMPLETED USING ANOTHER BIOPSY DEVICE. NO PATIENT INJURY (OTHER THAN A SECOND INCISION MADE) OR ANY ADVERSE EVENT WAS REPORTED RELATED TO THIS INCIDENT. THE INVOLVED BREVERA NEEDLE WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15555927 ↗
• MalfunctionJun 9, 2022Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON MAY 17TH THE CONSOLED DISPLAYED AN ERROR AND THE PROCEDURE HAD TO BE ABORTED AND THE PATIENT REQUIRED TO BE RESCHEDULED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14648713 ↗

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.