Brevera Breast Biopsy System BREVDISP09Recalls & reported problems

Summary

The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 15420045512863), received between Jun 21, 2021 and May 18, 2026 — classified as 107 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (53 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 25 most recent of 154 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Material Fragmentation

  IT WAS REPORTED THAT "POST CLIP MAMMO SHOWS SPECS AFTER USE OF BREVARA NEEDLE SYSTEM" ON (B)(6) 2025. THEY FURTHER REPORTED THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH THE SAME DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 25209461 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO PATIENTS UNDERWENT BREAST BIOPSY PROCEDURES USING A DISPOSABLE BREVERA BIOPSY DEVICE. IT WAS FURTHER REPORTED THAT THE PATIENTS LATER REPORTED "SIGNS OF INFECTION" AND "MENTIONED THAT SMALL PLASTIC-LIKE BEADS WERE EXPRESSED FROM THE BIOPSY SITE." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE USER SITE WERE UNSUCCESSFUL. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. DUE TO THE REPORT OF TWO IMPACTED PATIENTS, SEPARATE MDR'S WILL BE SUBMITTED FOR EACH PATIENT.

  Patient problems: Unspecified Infection

  MAUDE report 25174588 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO PATIENTS UNDERWENT BREAST BIOPSY PROCEDURES USING A DISPOSABLE BREVERA BIOPSY DEVICE. IT WAS FURTHER REPORTED THAT THE PATIENTS LATER REPORTED "SIGNS OF INFECTION" AND "MENTIONED THAT SMALL PLASTIC-LIKE BEADS WERE EXPRESSED FROM THE BIOPSY SITE." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE USER SITE WERE UNSUCCESSFUL. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. DUE TO THE REPORT OF TWO IMPACTED PATIENTS, SEPARATE MDR'S WILL BE SUBMITTED FOR EACH PATIENT.

  Patient problems: Unspecified Infection

  MAUDE report 25174474 ↗
• InjuryMay 14, 2026Material Fragmentation

  IT WAS REPORTED BY THE USER SITE THAT "PARTICLES [WERE] LEFT IN [A] PATIENT'S BREAST DURING [A BREVERA] BIOPSY PROCEDURE ON (B)(6) 2025." ADDITIONAL INFORMATION WAS OBTAINED FROM THE USER, AND IT IS REPORTED THAT AFTER MULTIPLE ATTEMPTS AT SAMPLING AND ADJUSTING THE DEVICE, THE CALCIFICATIONS WOULD NOT PULL INTO THE TROUGH. IT IS FURTHER REPORTED THAT BECAUSE THE TARGETED CALCIFICATIONS COULD NOT BE WELL SAMPLED AND THE "ARTIFACT SEEN IN THE BREAST AFTER BIOPSY WAS OF UNKNOWN ETIOLOGY," AN "EXCISIONAL BIOPSY WAS NECESSARY TO FULLY REMOVE THE ORIGINALLY TARGETED CALCIFICATIONS AND ALSO SERVED TO REMOVE THE SURROUNDING ARTIFACTS." IT IS REPORTED THAT THE ORIGINALLY TARGETED CALCIFICATIONS WERE BENIGN ACCORDING TO THE PATHOLOGY; HOWEVER, THE PATHOLOGIST "COULD NOT PROVIDE ANY ADDITIONAL DIAGNOSTIC INFORMATION ABOUT THE SPECIMEN AND NOTED THAT THERE IS NO CLEAR LITERATURE TO PROVIDE GUIDANCE IN CLEARLY IDENTIFYING SUCH FOREIGN MATERIAL." IT IS REPORTED THAT THE PATIENT IS ASYMPTOMATIC AND "THERE IS MINIMAL RESIDUAL (2MM OF ARTIFACT) SEEN CONFINED TO THE SKIN IN THE REGION OF THE EXCISION SCAR." NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25174384 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, POST PROCEDURE IMAGES REVEALED "NEW SCATTERED UNKNOWN ARTIFACTS." IT IS REPORTED THAT THE PATIENT WAS REFERRED TO A BREAST SURGEON FOR EXCISION OF THE AREA, WHICH WAS COMPLETED ON AN UNKNOWN DATE. MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM THE USER SITE WERE UNSUCCESSFUL. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24569758 ↗
• MalfunctionFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BREVERA BREAST BIOPSY PROCEDURE WAS COMPLETED ON AN UNKNOWN DATE; HOWEVER, THE PATHOLOGIST FROM THE HOSPITAL FOUND "A PIECE OF METAL" IN ONE OF THE SPECIMENS SENT TO THEM AFTER A BREVERA BIOPSY PROCEDURE. AS PER THE PHYSICIAN, THIS INCIDENT WAS NOT REPORTED TO HOLOGIC BEFORE. NO PATIENT HARM / INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322612 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A BREVERA BREAST BIOPSY PROCEDURE THAT OCCURRED ON (B)(6) 2026, THE PATIENT'S PATHOLOGY REPORT INDICATED "REFRACTILE FOREIGN MATERIAL." THE USER REPORTS THAT THERE WAS NO INDICATION THAT THE DEVICE WAS NOT FUNCTIONING, AND NO DEVICE DEFECTS WERE OBSERVED UPON COMPLETION OF THE PATIENT PROCEDURE. THE USER SITE WAS UNABLE TO PROVIDE THE DEVICE LOT AND THE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR FURTHER INVESTIGATION. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24193271 ↗
• InjuryJan 23, 2026Failure to Obtain Sample

  IT WAS REPORTED BY THE USER THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, "THE BIOPSY NEEDLE DID NOT TAKE SAMPLES, AND SUCTION DID NOT WORK. NO ERROR ON BREVERA MACHINE." ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER SITE IN WHICH IT WAS REPORTED, "TECHNOLOGIST TRIED TO FIGURE OUT WHAT WAS WRONG WITH SYSTEM IN THAT TIME PATIENT PASSED OUT AND RADIOLOGIST TOOK NEEDLE OUT. THE PROCEDURE WAS CANCELLED, AND WE HAD TO CALL 911." IT IS REPORTED THAT THE PATIENT WAS ASSESSED AND TAKEN TO THE EMERGENCY DEPARTMENT. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Syncope/Fainting

  MAUDE report 24165798 ↗
• InjuryDec 3, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6), 2025, THE USER SUCCESSFULLY TESTED THAT DISPOSABLE NEEDLE; HOWEVER, ONCE IT WAS INSERTED INTO THE BREAST FOR THE PROCEDURE, THE NEEDLE WOULD NOT PULL THE SALINE OR THE LIDOCAINE. IT IS REPORTED THAT THE BIOPSY PROCEDURE WAS UNSUCCESSFUL AND THE PROCEDURE WAS ABORTED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708822 ↗
• MalfunctionDec 3, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE USER SITE OBSERVED POSSIBLE FOREIGN MATERIAL IN THE ACQUIRED TISSUE SPECIMEN. THE USER SITE CONFIRMED VIA POST PROCEDURE IMAGING AND PATHOLOGY THAT NO FOREIGN MATERIAL WAS LEFT IN THE PATIENT'S BREAST. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704665 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, " THE BREVERA NEEDLE WAS MAKING A VERY LOUD NOISE WHILE FIRING INTO THE BREAST AND DURING SAMPLING. THE FIRST FEW SAMPLES DID NOT REGISTER ON THE IMAGE SCREEN. PATIENT ALSO STARTED YELLING THAT IT WAS HURTING AND ENDED UP WITH A HEMATOMA." A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND TESTED THE BREVERA SYSTEM AND FUNCTIONALITY OF COMPONENTS. THE FSE DETERMINED THAT THE SYSTEM FUNCTIONS PER MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Hematoma

  MAUDE report 23682661 ↗
• InjuryNov 6, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE DISPOSABLE NEEDLE WOULD NOT FIRE WHEN PROMPTED. THE USER SITE REPORTS THAT THE BREVERA DISPOSABLE NEEDLE WAS FULLY TESTED AND ARMED, AND NO ALARMS WERE DISPLAYED ON THE SYSTEM; HOWEVER, WHEN THE NEEDLE WAS IN THE PRE-FIRE POSITION, IT WOULD NOT FIRE WHEN PROMPTED. IT IS REPORTED THAT THE SYSTEM WAS REBOOTED AND A NEW NEEDLE WAS INSTALLED, ALLOWING THE USER TO COMPLETE THE PATIENT PROCEDURE. HOWEVER, THE USER REPORTS THAT WHILE TROUBLESHOOTING THE ISSUE, THE PATIENT REMAINED IN COMPRESSION, BECAME STRESSED AND HAD A VASOVAGAL EPISODE. THE USER REPORTS THAT THE PATIENT REQUIRED ATTENTION FROM THE MEDICAL ASSISTANT AT THE USER SITE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Altered State of Consciousness

  MAUDE report 23487592 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE USER SITE THAT TEN MINUTES AFTER A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE PATIENT BRIEFLY LOST CONSCIOUSNESS, WHICH WAS FOLLOWED BY CONFUSED SPEECH AND INVOLUNTARY MOVEMENTS OF THE HEAD AND LIMBS. IT IS FURTHER REPORTED BY THE USER SITE THAT EMERGENCY SERVICES WERE CALLED, THE PATIENT'S HEART RATE WAS ELEVATED AND SHE VOMITED; HOWEVER, BLOOD PRESSURE, OXYGEN SATURATION, RESPIRATORY RATE AND BLOOD GLUCOSE LEVELS WERE NORMAL THROUGHOUT. IT IS REPORTED THAT THE PATIENT DOES NOT HAVE ANY KNOWN ALLERGIES AND NO SWELLING OF THE FACE WAS OBSERVED. THE USER SITE REPORTS THAT THE PATIENT IMPROVED WHILE AWAITING EMERGENCY SERVICES TO ARRIVE, BUT THE INVOLUNTARY MOVEMENTS OF THE RIGHT ARM PERSISTED. THE USER SITE REPORTS THAT THE PATIENT PROVIDED AN UPDATE THAT THE REMAINING SYMPTOM RESOLVED AND THAT THE CT BRAIN SCAN WAS NORMAL; HOWEVER, THE PATIENT WAS AWAITING FURTHER NEUROLOGICAL ASSESSMENT. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Loss of consciousness; Movement Disorder

  MAUDE report 23302591 ↗
• InjurySep 16, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE CUSTOMER SITE THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE ANESTHETIC MEDICATION WAS NOT DELIVERED BY THE DEVICE, CAUSING THE PATIENT TO FEEL PAIN DURING THE PROCEDURE. IT IS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 23064446 ↗
• InjurySep 3, 2025Structural Problem; Insufficient Device Problem Information; Structural Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE USER OBSERVED THAT THE INTRODUCER EXTENDED TO THE TIP OF THE NEEDLE AND OBSERVED "RIGHT BREAST BUCKLING WITH SKIN NICK." ADDITIONAL INFORMATION WAS OBTAINED FROM THE USER SITE, AND IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE; HOWEVER, THE RADIOLOGIST PERFORMING THE PROCEDURE HAD TO USE A SCALPEL, MULTIPLE NEEDLES AND MADE A SECOND INCISION TO THE PATIENT'S BREAST. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956912 ↗
• InjuryAug 26, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE DEVICE MADE AND ABNORMAL SOUND. IT IS REPORTED THAT THE DEVICE TOOK THE SAMPLES AS EXPECTED; HOWEVER, DURING POST PROCEDURE IMAGING, THE USER OBSERVED APPARENT METALLIC FRAGMENTS IN THE PATIENT'S BREAST. THE USER REPORTS THAT UPON INSPECTION OF THE DEVICE, IT DOES NOT LOOK RIGHT. IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED; HOWEVER, THE USER IS UNABLE TO CONFIRM IF THE CALCIFICATIONS WERE RETRIEVED. NO MEDICAL INTERVENTION WAS REQUIRED AT THE TIME OF THE BIOPSY. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE BREVERA CONSOLE AND FOUND THERE WERE NO ERROR CODES, AND THE ISSUE APPEARED TO BE RELATED TO AN APPARENT DISPOSABLE NEEDLE FAILURE. THE FSE REVIEWED POST PROCEDURE IMAGES, WHICH APPEARED TO SHOW A METALLIC OBJECT BEHIND THE CLIP. THE FSE EVALUATED THE BREVERA CONSOLE AND REPORTS THAT ALL TESTS WERE GOOD. ADDITIONALLY, IT WAS REPORTED THAT ALL NEEDLES IN THE ASSOCIATED LOT WERE REMOVED FROM USE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. MEDSUN/MEDWATCH REPORT RECEIVED (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894700 ↗
• MalfunctionAug 20, 2025Break

  NOTHING UNUSUAL HAPPENED DURING THE PROCEDURE; HOWEVER, ON POST-PROCEDURE IMAGING, AN ARTIFACT WAS NOTED. AT THAT POINT, THE DEVICE (NEEDLE) WAS EXAMINED AND APPEARED ABNORMAL. THE BREVERA MACHINE OPERATES FINE, NO ERRORS (CHECKED OUT BY HOLOGIC). IT WAS THE DISPOSABLE NEEDLE THAT APPEARED BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849596 ↗
• InjuryJul 9, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2025, THE BIOPSY NEEDLE DID NOT COLLECT THE TISSUE SAMPLE. IT IS REPORTED THAT THE USER REPLACED THE VACUUM LINE ASSEMBLY; HOWEVER, DUE TO THE TISSUE ACQUISITION ISSUE, TWO PATIENTS HAD TO BE SCHEDULED FOR FOLLOW-UP APPOINTMENTS AFTER INCISION HAD ALREADY BEEN MADE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460390 ↗
• InjuryJul 9, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2025, THE BIOPSY NEEDLE DID NOT COLLECT THE TISSUE SAMPLE. IT IS REPORTED THAT THE USER REPLACED THE VACUUM LINE ASSEMBLY; HOWEVER, DUE TO THE TISSUE ACQUISITION ISSUE, TWO PATIENTS HAD TO BE SCHEDULED FOR FOLLOW-UP APPOINTMENTS AFTER INCISION HAD ALREADY BEEN MADE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460233 ↗
• MalfunctionJul 9, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2025, THE USER EXPERIENCED A SYSTEM ERROR WHEN ATTEMPTING TO FIRE THE DEVICE. THE DISPOSABLE AND THE SYSTEM WERE ALL TESTED PRIOR TO STARTING THE PROCEDURE, WITH NO ABNORMALITIES FOUND. REPORTING INDICATES THAT THE USER ATTEMPTED TO COMPLETE THE PROCEDURE WITH A SECOND NEEDLE, WHICH ALSO TESTED WITHOUT PROBLEM; HOWEVER, THE USER AGAIN EXPERIENCED A SYSTEM ERROR WHEN ATTEMPTING TO FIRE THE SECOND NEEDLE. THE SECOND NEEDLE WAS REMOVED FROM THE PATIENT AND INSPECTED, AT WHICH POINT IT IS REPORTED THAT A PIECE OF PLASTIC WAS OBSERVED IN THE APERTURE. THE BREVERA PROCEDURE WAS ABORTED AT THAT TIME AND THE USER SWITCHED TO A NEW DEVICE, WHICH REQUIRED A SECOND INCISION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE NEW DEVICE. A FIELD SERVICE ENGINEER (FSE) FROM THE DISTRIBUTOR VISITED THE SITE TO EXAMINE THE SYSTEM AND THE BREVERA CONSOLE WAS FOUND TO BE FUNCTIONING AS INTENDED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459323 ↗
• MalfunctionJul 9, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2025, THE USER EXPERIENCED A SYSTEM ERROR WHEN ATTEMPTING TO FIRE THE DEVICE. THE DISPOSABLE AND THE SYSTEM WERE ALL TESTED PRIOR TO STARTING THE PROCEDURE, WITH NO ABNORMALITIES FOUND. REPORTING INDICATES THAT THE USER ATTEMPTED TO COMPLETE THE PROCEDURE WITH A SECOND NEEDLE, WHICH ALSO TESTED WITHOUT PROBLEM; HOWEVER, THE USER AGAIN EXPERIENCED A SYSTEM ERROR WHEN ATTEMPTING TO FIRE THE SECOND NEEDLE. THE SECOND NEEDLE WAS REMOVED FROM THE PATIENT AND INSPECTED, AT WHICH POINT IT IS REPORTED THAT A PIECE OF PLASTIC WAS OBSERVED IN THE APERTURE. THE BREVERA PROCEDURE WAS ABORTED AT THAT TIME AND THE USER SWITCHED TO A NEW DEVICE, WHICH REQUIRED A SECOND INCISION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE NEW DEVICE. A FIELD SERVICE ENGINEER (FSE) FROM THE DISTRIBUTOR VISITED THE SITE TO EXAMINE THE SYSTEM AND THE BREVERA CONSOLE WAS FOUND TO BE FUNCTIONING AS INTENDED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22458486 ↗
• InjuryJun 16, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING A VACUUM ASSISTED BIOPSY PROCEDURE USING A BREVERA DEVICE, THE USER HEARD A GRINDING SOUND AND STOPPED THE PROCEDURE. THE USER REPORTS THAT THE SYSTEM WAS FLUSHED, PUT IN STANDBY AND WITH SOME MINOR RESISTANCE, THE NEEDLE WAS REMOVED FROM THE PATIENT. IT IS REPORTED THAT THE MARKER CLIP WAS PLACED, AND THE PLASTIC INTRODUCER SHEATH WAS DAMAGED BUT INTACT. ADDITIONALLY, THE USER REPORTS THAT THE POST PROCEDURE CLIP VIEWS REVEALED A METALLIC FOREIGN BODY THAT WAS NOT IN PREVIOUS IMAGING. THE USER REPORTS THAT UPON INSPECTION OF THE NEEDLE, THE DISTAL PORTION OF THE CUTTER WAS FRACTURED, AND A PORTION WAS MISSING. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22212048 ↗
• MalfunctionMay 20, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2025, THE USER HEARD A GRINDING NOISE DURING THE FIRST SAMPLE ACQUISITION. IT IS REPORTED THAT THE NEEDLE SEEMED TO "JUMP" AND IN THE FOURTH SPECIMEN, METAL SHAVINGS WERE OBSERVED. ADDITIONALLY, IT WAS REPORTED THAT THE SAMPLES WERE NOT AS BIG AS THEY TYPICALLY ARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT OR USER HARM WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055625 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2023, A SMALL SLIVER OF PLASTIC WAS SHAVING OFF THE CUT BLOCK AND WAS LOCATED IN THE PATIENT'S TISSUE. IT WAS REPORTED THAT THIS OCCURRED ON ANOTHER PATIENT LATER ON THAT MONTH AND THE CUSTOMER REPORTED A THIRD PIECE OF PLASTIC FOUND IN PATIENT TISSUE THE END OF THE NEXT MONTH. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 22036160 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2023, A SMALL SLIVER OF PLASTIC WAS SHAVING OFF THE CUT BLOCK AND WAS LOCATED IN THE PATIENT'S TISSUE. IT WAS REPORTED THAT THIS OCCURRED ON ANOTHER PATIENT LATER ON THAT MONTH AND THE CUSTOMER REPORTED A THIRD PIECE OF PLASTIC FOUND IN PATIENT TISSUE THE END OF THE NEXT MONTH. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 22036105 ↗

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.