Brevera Breast Biopsy SystemRecalls & reported problems across all models

We found 5 models of Brevera Breast Biopsy System by Hologic, Inc. in the FDA's device registry (GUDID). Together they are named in 300 adverse event reports in the FDA's MAUDE database, received between Apr 3, 2020 and May 18, 2026 — classified as 223 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (131 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Brevera Breast Biopsy System problems

Brevera Breast Biopsy System models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Brevera Breast Biopsy System BREVDISP09

  INSTRUMENT, BIOPSY
  154 reports
• Brevera Breast Biopsy System BREV100

  INSTRUMENT, BIOPSY
  74 reports
• Brevera Breast Biopsy System BREVDRV

  INSTRUMENT, BIOPSY
  61 reports
• Brevera Breast Biopsy System BREV200

  INSTRUMENT, BIOPSY
  7 reports
• Brevera Breast Biopsy System BREV09

  INSTRUMENT, BIOPSY
  4 reports

Recent Brevera Breast Biopsy System adverse event reports

The 15 most recent reports across all models, 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, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2026, THE USER EXPERIENCED DEVICE SUCTION ISSUES, IN WHICH THE TISSUE SAMPLE WAS NOT BEING COMPLETELY PLACED IN THE SAMPLE CHAMBER. ADDITIONALLY, THE USER REPORTS THAT THE LIDOCAINE WAS NOT FLOWING WELL THROUGH THE DEVICE. THE USER REPORTS THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED; HOWEVER, THE PATIENT FELT SOME PAIN AND ADDITIONAL LIDOCAINE ADMINISTRATION WAS REQUIRED VIA HAND BOLUS. MDR IS BEING SUBMITTED DUE TO THE REPORTED PAIN AND ADDITIONAL MEDICAL INTERVENTION REQUIRED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE AND WAS UNABLE TO REPLICATE THE USER'S REPORTED ISSUE; HOWEVER, DID REPLACE A LOOSE VALVE. THE FSE REPORTS THE DEVICE IS OPERATIONAL. NO FURTHER DETAILS ARE CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 24168409 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2026, THE USER EXPERIENCED DEVICE SUCTION ISSUES, IN WHICH THE TISSUE SAMPLE WAS NOT BEING COMPLETELY PLACED IN THE SAMPLE CHAMBER. ADDITIONALLY, THE USER REPORTS THAT THE LIDOCAINE WAS NOT FLOWING WELL THROUGH THE DEVICE. THE USER REPORTS THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED; HOWEVER, THE "PATIENT FELT SEVERE PAIN CAUSING VOMITING AND LOW BLOOD PRESSURE; VASO VAGAL FEELINGS." MDR IS BEING SUBMITTED DUE TO THE REPORTED PAIN AND CLINICAL SYMPTOMS EXPERIENCED BY THE PATIENT. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE AND WAS UNABLE TO REPLICATE THE USER'S REPORTED ISSUE; HOWEVER, DID REPLACE A LOOSE VALVE. THE FSE REPORTS THE DEVICE IS OPERATIONAL. NO FURTHER DETAILS ARE CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Low Blood Pressure/ Hypotension; Vomiting

  MAUDE report 24167398 ↗
• 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 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE USER EXPERIENCED A DEVICE DRIVER ERROR SEVERAL TIMES EVEN AFTER REPLACING THE DRIVER. IT IS REPORTED THAT HOLOGIC TECHNICAL SUPPORT ASSISTED THE USER WITH TROUBLESHOOTING AND RESOLVING THE REPORTED DRIVER ERRORS AND THE PATIENT PROCEDURE WAS SUCCESSFULLY COMPLETED; HOWEVER, AN ADDITIONAL INCISION WAS REQUIRED TO DO SO. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23966693 ↗
• 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 ↗
• InjuryDec 16, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE USER SITE THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, "WE HAD A DEVICE DRIVER ERROR IN THE MIDDLE OF A BIOPSY. THE DEVICE FIRED INTO THE BREAST BUT WOULD NOT TAKE SAMPLE." THE USER SITE REPORTS THAT DUE TO THE DRIVER ERROR, THE STEREO BIOPSY WAS ABORTED, AND THE PATIENT PROCEDURE WAS COMPLETED UNDER ULTRASOUND; HOWEVER, AN ADDITIONAL INCISION TO THE PATIENT WAS REQUIRED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE SYSTEM AND DETERMINED THAT A DRIVER ERROR DISPLAYED DURING THE PROCEDURE AND THE DRIVER BECAME UNRESPONSIVE. THE FSE EVALUATED THE DRIVER AND FOUND NO DRIVER MOVEMENT. THE FSE REPLACED THE SYSTEM DRIVER AND REPORTS THAT THE SYSTEM MEETS MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816690 ↗
• InjuryDec 4, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE USER THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, "ERRORS OCCURRING DURING PROCEDURE AFTER NEEDLE WAS FIRED INTO THE PATIENT'S BREAST, UNABLE TO CLEAR. REBOOTED SYSTEM SEVERAL TIMES, ERROR STILL PRESENT. SWITCHED TO DIFFERENT NEEDLE, ATTEMPTED TO GO THROUGH SETUP, ERROR RETURNED. REBOOTED SYSTEM WITH DRIVER DISCONNECTED, ERROR RETURNED WHEN DRIVER WAS RECONNECTED." THE PATIENT PROCEDURE WAS NOT COMPLETED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE SYSTEM AND DETERMINED THAT THE SYSTEM DRIVER NEEDS TO BE REPLACED. THE FSE REPLACED THE DRIVER, TESTED THE SYSTEM AND REPORTS THAT THE SYSTEM MEETS ALL MANUFACTURING STANDARDS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717202 ↗
• 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 ↗

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