Brevera Breast Biopsy System BREVDRVRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 15420045507760), received between May 5, 2023 and Jan 5, 2026 — classified as 59 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (45 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 61 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 DISPOSABLE NEEDLE WOULD NOT SUCTION. THE USER SITE REPORTS THAT THE DISPOSABLE NEEDLE TESTED WITHOUT ISSUE; HOWEVER, AFTER FIRING, IT WOULD NOT SAMPLE, PULL SALINE OR ADMINISTER LIDOCAINE. IT WAS REPORTED THAT THE DISPOSABLE NEEDLE WAS REPLACED AND AGAIN TESTED WITHOUT ISSUE, BUT THEN THE REMOTE DRIVER STOPPED WORKING AND THE DEVICE DISPLAYED AN ERROR. IT IS REPORTED THAT THE PATIENT PROCEDURE COULD NOT BE COMPLETED AND THE PATIENT WAS RESCHEDULED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) IN CONJUNCTION WITH REMOTE HOLOGIC TECHNICAL SUPPORT WERE DISPATCHED TO EXAMINE THE DEVICE. IT IS REPORTED THAT THE FSE TESTED THE SYSTEM WITH A TEST NEEDLE AND THE SYSTEM PASSED TESTING. IT IS FURTHER REPORTED THAT TECHNICAL SUPPORT LOGGED INTO THE SYSTEM REMOTELY AND UPDATED THE NODE SOFTWARE. THE SYSTEM WAS AGAIN TESTED WITH TECHNICAL SUPPORT STILL REMOTELY LOGGED IN AND THE SYSTEM PASSED TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708687 ↗
• InjuryDec 3, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE USER SITE EXPERIENCED A SYSTEM DRIVER ERROR. IT IS REPORTED THAT THE RADIOLOGIST TARGETED AND FIRED THE DEVICE INTO THE PATIENT'S BREAST BUT THEN DECIDED TO REMOVE THE NEEDLE AND RETARGET WHEN THE DEVICE ERROR OCCURRED. THE USER SITE REPORTS THAT THE NEEDLE REMAINED IN THE PATIENT'S BREAST WHILE ATTEMPTING TO OBTAIN SUPPORT FROM HOLOGIC TECHNICAL SUPPORT; HOWEVER, THE USER EVENTUALLY DECIDED TO REMOVE THE NEEDLE, AND THE PROCEDURE WAS NOT COMPLETED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE AND REVIEW SYSTEM LOGS. THE FSE FOUND THAT THE ERROR OCCURRED WHEN THE SYSTEM PROMPTED THAT THE INTRODUCER WAS NOT INSTALLED. A PETITE INTRODUCER WAS INSTALLED IN THE INCORRECT MODE, THEN REMOVED, ALSO IN THE INCORRECT MODE, WHICH GENERATED A "NEEDLE DISCONNECTED IN BIOPSY" AND "DEVICE DRIVER ARMED IN INVALID STATE" SYSTEM ERRORS. THE FSE RESTARTED THE DEVICE, CLEARED THE ERRORS, AND PERFORMED SYSTEM TESTS WITH THE EXISTING DEVICE DRIVER. THE FSE REPORTS THAT NO SYSTEM ISSUE WAS FOUND, THE SYSTEM PASSED ALL TESTS AND MEETS MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705962 ↗
• InjuryNov 20, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE USER SITE EXPERIENCED A SYSTEM ERROR. IT IS REPORTED THAT TROUBLE SHOOTING WAS DONE IN WHICH THE USER SITE REMOVED THE NEEDLE FROM THE PATIENT'S BREAST, POWERED OFF THE UNIT AND INSTALLED A NEW NEEDLE FROM THE SAME LOT. THE USER SITE REPORTS THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, A SECOND INCISION WAS REQUIRED TO THE PATIENT'S BREAST TO DO SO. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE AND HEARD A "GRINDING" NOISE COMING FROM THE DEVICE DRIVER DURING HOMING. THE FSE REPLACED THE DEVICE DRIVER AND CONFIRMED THAT THE SYSTEM IS NOW OPERATIONAL. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605627 ↗
• InjuryNov 17, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED BY THE USER SITE THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THERE WAS NO SUCTION, AND THE DEVICE DISPLAYED SYSTEM ERRORS. IT WAS REPORTED THAT THE TECHNOLOGIST WAS ABLE TO CLEAR THE ERRORS BUT WAS UNABLE TO GET THE DEVICE INTO A READY STATE. THE USER SITE REPORTS THAT ALL TUBING WAS CHECKED TO ENSURE PROPER PLACEMENT, THE CANNISTER WAS CHECKED FOR CRACKS, THE DEVICE WAS SHUT DOWN AND RESTARTED A FEW TIMES IN ADDITION TO ATTEMPTING TO USE NEW NEEDLES; HOWEVER, THESE TROUBLESHOOTING ATTEMPTS WERE UNSUCCESSFUL. IT IS REPORTED THAT AN INCISION AND NEEDLE INSERTION HAD ALREADY OCCURRED WHEN THE PATIENT PROCEDURE WAS ABORTED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE. THE FSE IN CONJUNCTION WITH HOLOGIC TECHNICAL SUPPORT DETERMINED THAT THE DEVICE DRIVER WAS NOT FUNCTIONING PROPERLY. THE FSE REPLACED THE DRIVER, COMPLETED SYSTEM TESTS AND COMPLETED A FULL BIOPSY CYCLE WITHOUT ISSUES. THE FSE REPORTS THAT THE SYSTEM PASSED ALL TESTS AND MEETS MANUFACTURER SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569197 ↗
• InjuryOct 31, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE USER EXPERIENCED SYSTEM ERRORS AFTER THE NEEDLE WAS FIRED INTO THE PATIENT'S BREAST AND WAS UNABLE TO BEGIN TISSUE SAMPLING. IT IS FURTHER REPORTED THAT THE USER SITE REBOOTED THE SYSTEM; HOWEVER, THE ERROR RETURNED AFTER RESTART. ADDITIONALLY, IT IS REPORTED THAT THE USER SITE DISCONNECTED THE DEVICE DRIVER, REBOOTED THE SYSTEM AGAIN AND THE ERROR AGAIN RETURNED UPON STARTUP. REPORTING FROM THE USER SITE INDICATES THAT THE PATIENT PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE DEVICE AND FOUND THE DEVICE DRIVER WAS JAMMED. THE FSE MANUALLY CLEARED THE JAM AND ATTEMPTED TO COMPLETE A TEST CYCLE, BUT THE DRIVER JAMMED AGAIN. THE FSE INSTALLED A NEW DEVICE DRIVER, PERFORMED SYSTEM TESTS AND CALIBRATIONS AND CONFIRMED THAT THE DEVICE IS FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435971 ↗
• InjuryOct 21, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE USER EXPERIENCED ISSUES WITH THE DEVICE FOOTSWITCH NOT OBTAINING SAMPLES, CAPTURING, OR DISPLAYING SAMPLE IMAGES. IT IS REPORTED THAT DURING THE BIOPSY PROCEDURE, THE DEVICE SOUNDED NORMAL; HOWEVER, NO SAMPLES WERE ACQUIRED. ADDITIONALLY, THE USER REPORTS THAT BLOOD AND SALINE WERE FLOWING THROUGH THE DEVICE INTO THE CHAMBER. THE USER REPORTS THAT THE DISPOSABLE NEEDLE WAS CHANGED BUT THE DEVICE CONTINUED TO DISPLAY THE SAME BEHAVIOR. IT IS REPORTED THAT WHEN THE DISPOSABLE NEEDLE WAS CHANGED, THE USER RECEIVED A SYSTEM ERROR WHICH CLEARED UPON REBOOT. IT IS REPORTED THAT DUE TO THE ISSUES EXPERIENCED BY THE USER SITE, THE PATIENT WAS RESCHEDULED; HOWEVER, A SKIN INCISION HAD ALREADY OCCURRED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED DEVICE ISSUES. THE FSE REPORTS THAT THE WORKFLOW WAS REVIEWED WITH THE USER, THE BREVERA DEVICE WAS TESTED, AND THE SYSTEM MEETS MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351985 ↗
• InjurySep 23, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE DEVICE WOULD NOT FIRE. IT IS REPORTED THAT THE USER DID NOT OBSERVE ANY SYSTEM ERRORS AT THE TIME OF THE EVENT. THE USER REPORTS THAT THE DEVICE WAS UNPLUGGED AND PLUGGED BACK IN; HOWEVER, THE ISSUE DID NOT RESOLVE, AND THE PROCEDURE WAS ABORTED AFTER THE DEVICE HAD ALREADY BEEN INSERTED INTO THE PATIENT'S BREAST. IT IS REPORTED THAT TROUBLESHOOTING WAS LATER DONE WITH THE USER AND HOLOGIC TECHNICAL SUPPORT AT WHICH TIME THE USER WAS INSTRUCTED TO SHUT THE UNIT COMPLETELY DOWN, A TEST RUN WAS COMPLETED FROM START TO FINISH AND THE DEVICE FIRED WITHOUT AN ISSUE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23123853 ↗
• InjurySep 4, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE USER HAD THE NEEDLE GUIDE AND NEEDLE IN WHEN THE TUBING ATTACHED TO THE DRIVER HANDPIECE WAS INADVERTENTLY PULLED OUT. IT IS REPORTED THAT AS A RESULT OF THE USER INADVERTENTLY PULLING THE TUBING OUT, THE PROCEDURE COULD NOT BE COMPLETED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE DEVICE. THE FSE INSTALLED A NEW DRIVER ON THE BREVERA, TESTED SYSTEM FUNCTIONALITY WITH A TEST NEEDLE, AND CONFIRMED THAT THE DEVICE IS FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22967076 ↗
• InjurySep 4, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE BREVERA NEEDLE FAILED THREE TIMES, AND A DRIVER ERROR WAS OBSERVED. THE USER REPORTS THAT IN EACH INSTANCE, ONCE THE NEEDLE WAS PLACED INSIDE THE PATIENT'S BREAST AND FIRED, THE DEVICE MADE AN ABNORMAL SOUND AND APPEARED TO COME OFF TRACK. THE USER REPORTS THAT UPON THE FIRST OCCURRENCE, THE BREVERA UNIT WAS RESTARTED, AND SUCCESSFULLY PASSED THE PRE-TEST BUT ONCE THE NEEDLE WAS PLACED INSIDE THE PATIENT'S BREAST AND FIRED, THE DEVICE MADE AN ABNORMAL SOUND AND APPEARED TO COME OFF TRACK. IT IS REPORTED THAT IN THE SECOND OCCURRENCE, THE UNIT WAS COMPLETELY RESTARTED USING INSTRUCTIONS FROM HOLOGIC TECHNICAL SUPPORT AND THE DEVICE AGAIN SUCCESSFULLY PASSED THE PRE-TEST, BUT ONCE THE NEEDLE WAS PLACED INSIDE THE PATIENT'S BREAST AND FIRED, THE DEVICE MADE AN ABNORMAL SOUND AND APPEARED TO COME OFF TRACK. ON THE THIRD ATTEMPT, THE USER REPORTS THAT THE BIOPSY DISPOSABLE WAS REPLACED AND AGAIN SUCCESSFULLY PASSED THE PRE-TEST; HOWEVER, ONCE THE NEEDLE WAS PLACED INSIDE THE PATIENT'S BREAST AND FIRED, THE DEVICE MADE AN ABNORMAL SOUND AND APPEARED TO COME OFF TRACK. THE PROCEDURE WAS ABORTED AFTER THE THI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964479 ↗
• InjurySep 3, 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 DEVICE DISPLAYED AN ERROR CODE INDICATING AN ISSUE WITH THE DEVICE DRIVER. IT IS REPORTED THAT AT THE TIME THE ERROR OCCURRED, THE PATIENT WAS IN COMPRESSION AND A SKIN INCISION HAD BEEN MADE. IT IS REPORTED THAT DUE TO THE SYSTEM ERROR, THE PROCEDURE COULD NOT BE COMPLETED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE DEVICE AND WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE FSE TESTED THE DEVICE WITH A PREVENTATIVE MAINTENANCE TEST KIT AS WELL AS WITH A NEEDLE FROM ANOTHER LOT AT THE CUSTOMER SITE AND ALL TESTS WERE GOOD. THE FSE CONCLUDED THAT THE ISSUE THE CUSTOMER EXPERIENCED WAS POSSIBLY RELATED TO THE DISPOSABLE NEEDLE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955867 ↗
• InjurySep 2, 2025Failure to Obtain Sample; Mechanical Jam; Failure to Obtain Sample; Mechanical Jam

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE USER EXPERIENCED A DRIVER ERROR. IT IS REPORTED THAT THE USER STEPPED ON THE FOOT PEDAL TO INITIATE THE BIOPSY, AND THE DRIVER ERROR OCCURRED IMMEDIATELY AFTER, AT WHICH TIME THE BREVERA DEVICE WOULD NOT RESPOND. FURTHER REPORTING FROM THE USER INDICATES THAT THE PATIENT HAD TO BE RESCHEDULED AFTER THE NEEDLE HAD ALREADY BEEN INSERTED INTO THE PATIENT'S BREAST. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE AND DETERMINED THAT THE DEVICE DRIVER WAS THE ISSUE BASED ON SYSTEM LOGS AND TROUBLESHOOTING. THE FSE REPLACED THE DRIVER, TESTED THE DEVICE AND CONFIRMED THAT THE SYSTEM IS NOW FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22940060 ↗
• InjuryJul 9, 2025Failure to Obtain Sample; Failure to Fire; Failure to Obtain Sample; Failure to Fire

  IT WAS REPORTED THAT DURING A DENSE TISSUE BIOPSY ON (B)(6) 2025, THE DRIVER ON A BREVERA DEVICE BEGAN MAKING ABNORMAL NOISES AND DISPLAYED TWO ERROR CODES. THE USER REPORTED THAT THE DEVICE WOULD NOT FIRE OR RESET DESPITE A FULL SHUTDOWN AND DISCONNECT OF THE DEVICE. AS A RESULT, IT IS REPORTED THAT THE PATIENT'S PROCEDURE WAS RESCHEDULED DUE TO INADEQUATE TISSUE COLLECTION. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE AND INSTALLED A NEW DRIVER ON THE SYSTEM. THE FSE PERFORMED SYSTEM TESTS WITH THE NEW DRIVER AND REPORTS THAT THE SYSTEM IS OPERATING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460082 ↗
• InjuryJul 8, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2025, THE USER EXPERIENCED SYSTEM ERRORS AND HEARD AN ABNORMAL NOISE WHEN THE DEVICE WAS FIRED. THE DISPOSABLE AND THE SYSTEM WERE ALL TESTED BEFORE STARTING THE PROCEDURE, WITH NO ABNORMALITIES FOUND. IT WAS REPORTED THAT THE USER MADE TWO ATTEMPTS TO TROUBLESHOOT THE DEVICE AND COMPLETE THE PROCEDURE WITH THE BREVERA. THE EFFORTS TO TROUBLESHOOT WERE UNSUCCESSFUL; THEREFORE, THE USER SWITCHED TO A NEW DEVICE, WHICH REQUIRED A SECOND INCISION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE NEW DEVICE. A FIELD ENGINEER FROM THE DISTRIBUTOR VISITED THE SITE ON (B)(6) 2025, TO EXAMINE THE SYSTEM. THE CONSOLE WAS CHECKED USING A TEST-NEEDLE AND THE REPORTED ABNORMAL NOISE WAS HEARD. ADDITIONALLY, THE NEEDLE COULD BE FIRED; HOWEVER, THE BIOPSY WAS DIFFICULT TO PERFORM. THE DRIVER WAS ALSO EXAMINED, AND ALL MOVEMENTS WERE AS EXPECTED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437280 ↗
• InjuryJun 9, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED ON (B)(6) 2025, THAT DURING A BREVERA PROCEDURE, THE DEVICE DRIVER WOULD NOT FIRE AFTER THE PATIENT WAS ALREADY IN COMPRESSION AND THE NEEDLE HAD ALREADY BEEN INSERTED. IT IS REPORTED THAT THE CUSTOMER ATTEMPTED TO TROUBLESHOOT THE ISSUE WITH THE ASSISTANCE OF HOLOGIC TECHNICAL SUPPORT VIA THE TELEPHONE; HOWEVER, IT DID NOT RESOLVE THE ISSUE. AS A RESULT, THE PROCEDURE COULD NOT BE COMPLETED, AND THE PATIENT WAS RESCHEDULED. A FIELD ENGINEER WAS DISPATCHED TO ASSESS THE DEVICE, AND FOUND THE DEVICE WAS INDICATING THAT THE DEVICE DRIVER WAS NOT RECOGNIZED. THE FIELD ENGINEER INDICATES THAT A REVIEW OF SYSTEM LOGS SHOWED SEVERAL ERRORS ASSOCIATED WITH NEEDLE REMOVAL AND THE ARRAY NOT HAVING COMMUNICATION WITH THE SYSTEM. IT IS REPORTED THAT THE FIELD ENGINEER PERFORMED SYSTEM CALIBRATIONS, WHICH ALLOWED THE DEVICE DRIVER TO BE RECOGNIZED. THE FIELD ENGINEER CONFIRMED THAT THE SYSTEM IS NOW READY FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168126 ↗
• InjuryJun 3, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2025, THE CUSTOMER EXPERIENCED A DEVICE ERROR CODE AFTER THE NEEDLE HAD ALREADY BEEN INSERTED INTO THE PATIENT. THE CUSTOMER REPORTS THAT THE PROCEDURE COULD NOT BE COMPLETED AND THE PATIENT WAS RESCHEDULED. A FIELD ENGINEER WAS DISPATCHED TO EXAMINE THE DEVICE AND DETERMINED THAT THE DEVICE DRIVER NEEDED TO BE REPLACED. THE FIELD ENGINEER REPLACED THE DRIVER AND CONFIRMED THAT THE SYSTEM IS NOW FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22132299 ↗
• InjuryJun 2, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2025, THE DEVICE DRIVER DID NOT FIRE. THE CUSTOMER REPORTED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE; HOWEVER, THE PATIENT REQUIRED ADDITIONAL MEDICATION AND A SECOND INCISION. A FIELD ENGINEER WAS DISPATCHED TO ASSESS THE EQUIPMENT, AND IT WAS DETERMINED THAT DEVICE CODE AND FILES REQUIRED RELOADING AND DEFAULTS WERE RESTORED. THE FIELD ENGINEER REPORTS THE SYSTEM PASSED ALL TESTS AND IS FUNCTIONING PER MANUFACTURER SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127363 ↗
• InjuryJun 2, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2025, THE CUSTOMER RECEIVED A DRIVER ERROR AFTER THE BIOPSY NEEDLE HAD ALREADY BEEN INSERTED INTO THE PATIENT. AS IT WAS NOT POSSIBLE TO CONTINUE THE BIOPSY, THE CUSTOMER REMOVED THE NEEDLE FROM THE BREAST, RESTARTED THE DEVICE, AND ATTEMPTED TO COMPLETE THE BIOPSY WITH A SECOND NEEDLE. HOWEVER, THE DRIVER ERROR PERSISTED, AND THE PROCEDURE WAS ABORTED. NO SAMPLES COULD BE TAKEN, AND THE PATIENT WAS RESCHEDULED TO UNDERGO ANOTHER BIOPSY AT A LATER DATE. A FIELD ENGINEER WAS DISPATCHED TO EXAMINE THE EQUIPMENT AND FOUND THE DEVICE GEARBOX WAS JAMMED. THE FIELD ENGINEER RECTIFIED THE JAMMED GEARBOX AND PERFORMED SEVERAL TEST RUNS WITH NO ABNORMALITIES. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125497 ↗
• InjuryJun 2, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2025, THE CUSTOMER RECEIVED A "DRIVER ERROR" AND WAS UNABLE TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD TO BE RESCHEDULED AFTER A SKIN INCISION HAD ALREADY BEEN MADE. A FIELD ENGINEER WAS DISPATCHED TO ASSESS THE DEVICE AT WHICH TIME THE INTERNAL SCREWS WERE TIGHTENED, AND ALL MECHANICS WERE LUBRICATED. THE FIELD ENGINEER PERFORMED A COMPLETE NEEDLE TEST WITHOUT ISSUE AND CONFIRMED THAT THE DEVICE IS NOW FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122570 ↗
• InjuryMay 28, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2025, THE CUSTOMER EXPERIENCED AN ERROR AND NO SUCTION ON THE DEVICE WHILE COLLECTING SAMPLES. THE CUSTOMER REPORTS THAT THE TUBING HAD TO BE CUT TO RETRIEVE THE SAMPLES AND THE PROCEDURE COULD NOT BE COMPLETED. A FIELD ENGINEER WAS DISPATCHED TO EXAMINE THE EQUIPMENT AND DETERMINED THAT THE DRIVER NEEDED TO BE REPLACED. THE FIELD ENGINEER REPLACED THE DRIVER, PERFORMED THE NECESSARY CALIBRATIONS AND CONFIRMED THAT THE SYSTEM IS NOW FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22098585 ↗
• InjuryMay 22, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING A BREVERA PROCEDURE, THE DEVICE PASSED THE INITIAL SET UP CHECKS BUT AFTER THE NEEDLE WAS INSERTED INTO THE PATIENT, AN ERROR DISPLAYED, AND THE DEVICE STOPPED FUNCTIONING. THE CUSTOMER REPORTS THAT TROUBLESHOOTING ATTEMPTS WERE MADE; HOWEVER, THE CUSTOMER WAS UNABLE TO CLEAR THE ERROR AND THE PROCEDURE WAS ABORTED. A FIELD ENGINEER WAS DISPATCHED TO EXAMINE THE EQUIPMENT AND RECEIVED AN ERROR RELATED TO THE DRIVER. THE SYSTEM WAS RETESTED AND AFTER TROUBLESHOOTING NO ERROR WAS OBSERVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070753 ↗
• InjuryApr 25, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2025, DURING A BIOPSY THE CUSTOMER GOT A DRIVER ERROR. THE ERROR COULD NOT BE CLEARED AND 2 NEEDLES WERE USED. THE PROCEDURE WAS ABORTED AND THE PATIENT RESCHEDULED. ONLY ONE SPECIMEN COULD BE OBTAINED. AN FE EXAMINED CONSOLE AND DETERMINED THAT 5 TORQUE SCREWS ON THE DRIVER WERE LOOSED. SCREWS WERE TIGHTENED AND TESTED THE DRIVER. SYSTEM PERFORMED AS MANUFACTURER´S SPECIFICATIONS. THE NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914562 ↗
• InjuryApr 9, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2025, THE TECHNICIAN REPORTED THAT DRIVER ERRORS WERE EXPERIENCED. SYSTEM WAS SHUTDOWN AND RESTARTED BUT SYSTEM KEPT GIVING THE ERRORS. PROCEDURE COULD NOT BE COMPLETED AND THE PATIENT HAD THE NEEDLE INSERTED INTO HER BREAST. THE PROCEDURE WAS RESCHEDULED. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND DISCONNECTED THE DRIVER CABLE AND RECONNECTED THE DRIVER BACK UP. THE CONSOLE WAS ABLE TO RECOGNIZE THE DRIVER AND WORKED AS INTENDED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21810024 ↗

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.