Brevera Breast Biopsy System BREV100Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 15420045507517), received between Jul 7, 2022 and Jan 23, 2026 — classified as 53 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (30 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 74 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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, "IMAGING SYSTEM ERROR" AND "NO FILTER FOUND" ERRORS WERE OBSERVED. IT IS REPORTED THAT THE NEEDLE WAS FIRED INTO THE PATIENT'S BREAST IN PREPARATION TO OBTAIN SAMPLES; HOWEVER, WHEN THE RADIOLOGIST ATTEMPTED TO OBTAIN THE FIRST SAMPLE, THE SYSTEM DISPLAYED THE "NO FILTER FOUND" ERROR. THE USER REPORTS THAT TROUBLESHOOTING WAS ATTEMPTED BY OPENING AND CLOSING THE SYSTEM DRAWER AND CHANGING THE FILTER, BUT THE PROCEDURE COULD NOT BE COMPLETED. THE USER REPORTS THAT THE NEEDLE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS RESCHEDULED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE AND IN CONJUNCTION WITH HOLOGIC REMOTE TECHNICAL SUPPORT, WAS ABLE TO CLEAR THE "NO FILTER FOUND" ERROR BY RELOADING CODE TO THE DEVICE. DESPITE CLEARING THE ERROR, THE FSE REPORTS THAT THE FILTER CHAMBERS WERE MISALIGNED WHEN IMAGING. THE FSE COMPLETED TRAY ALIGNMENT AND MOTOR ACCURACY TESTS, BUT THIS DID NOT COMPLETELY RESOLVE THE MISALIGNMENT. THE FSE PROVIDED THE USER SITE WITH INFORMATION REGARDING CORLUMINA REPLACEMENT AS WELL AS ENTIRE DEVICE REPLACEMENT. THE USER SITE IS PE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572284 ↗
• InjuryOct 17, 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 ACQUIRING TISSUE SAMPLES IN THE SPECIMEN FILTER. IT IS REPORTED THAT THE PROCEDURE COULD NOT BE COMPLETED AND THE PATIENT WAS RESCHEDULED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE AND TESTED THE DEVICE WITH TWO NEEDLES FROM THE LOT THE USER WAS REPORTEDLY USING AT THE TIME OF THE ISSUE AS WELL AS A NEEDLE FROM A NEW LOT. THE FSE REPORTS THAT FULL BIOPSY PROCEDURES WERE TESTED IN CONJUNCTION WITH A USER SITE TECHNOLOGIST, INCLUDING UTILIZING THE LIDOCAINE WASH, SALINE AND TISSUE ACQUISITION. IT IS REPORTED THAT ALL THREE NEEDLES PASSED PRE-TESTING, SUCCESSFULLY BIOPSIED AND THE SAMPLES WERE ACQUIRED IN THE TISSUE FILTER AS INTENDED. THE FSE WAS UNABLE TO FIND ANY DEVICE RELATED ISSUES AND CONFIRMED THAT THE BREVERA DEVICE IS PROPERLY FUNCTIONING. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23327514 ↗
• InjuryOct 16, 2025Calibration Problem; Adverse Event Without Identified Device or Use Problem; Calibration Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE FILTER WOULD INTERMITTENTLY FAIL TO ADVANCE, RESULTING IN THE PATIENT SAMPLES BEING DISTRIBUTED IN ONLY ONE CHAMBER. IT IS REPORTED THAT THE USER SITE SWITCHED TO A DIFFERENT NEEDLE AND WAS ABLE TO COMPLETE THE PATIENT PROCEDURE WITHOUT EXPERIENCING ANY ADDITIONAL ISSUES; HOWEVER, A SECOND INCISION TO THE PATIENT WAS REQUIRED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE UNIT AND PERFORMED A FILTER CALIBRATION. THE FSE VERIFIED MULTIPLE FILTER WHEELS COMPLETED IMAGING AND ADVANCED TO THE PROPER LOCATION. SYSTEM IS OPERATING PER MANUFACTURE SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Laceration(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316714 ↗
• InjurySep 3, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY ON (B)(6) 2025, THE USER EXPERIENCED AN UNKNOWN ERROR IN WHICH THE RADIOLOGIST TOOK TWO SAMPLES AND THE UNIT THEN STOPPED. IT WAS REPORTED THAT THE UNIT WOULD NOT TAKE ANY ADDITIONAL SAMPLES, AND NO ERROR CODE WAS DISPLAYED. REPORTING INDICATES THAT THE PATIENT HAD A SYNCOPAL EPISODE AFTER THE TWO SAMPLES WERE TAKEN AND THE PROCEDURE WAS NOT CONTINUED WITH A NEW NEEDLE. THE USER REPORTS THAT THE PATIENT WILL NEED TO RETURN FOR ANOTHER BIOPSY TO ENSURE THE FULL AREA WAS SAMPLED APPROPRIATELY. HOLOGIC TECHNICAL SUPPORT WORKED WITH THE CUSTOMER REMOTELY ON THE REPORTED ISSUE. A REVIEW OF SYSTEM LOGS SHOWED MULTIPLE IMAGER ERRORS AND FAILED CALIBRATIONS. HOLOGIC TECHNICAL SUPPORT REVIEWED HOW TO SUCCESSFULLY PERFORM THE AUTO GAIN CALIBRATION WITH THE CUSTOMER. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Syncope/Fainting

  MAUDE report 22956404 ↗
• InjuryAug 19, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE SYSTEM PASSED THE SET-UP PROCESS WITHOUT ISSUE; HOWEVER, AFTER THE NEEDLE WAS INSERTED INTO THE PATIENT'S BREAST, THE FOOT PEDAL WOULD NOT RESPOND AND AN ERROR MESSAGE DIRECTING THE USER TO REPLACE THE FOOT PEDAL DISPLAYED. IT IS REPORTED THAT DUE TO THE LACK OF RESPONSE FROM THE FOOT PEDAL, THE USER WAS UNABLE TO SAMPLE, AND THE PROCEDURE WAS ABORTED. IT IS REPORTED THAT THE PATIENT WAS RESCHEDULED, WHICH WILL REQUIRE A SECOND INCISION. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE EQUIPMENT AND DETERMINED THAT THE FOOT PEDAL NEEDED TO BE REPLACED, WHICH WAS COMPLETED AT THAT TIME. THE FSE, IN CONJUNCTION WITH THE USER, TESTED THE REPLACED FOOT PEDAL AND CONFIRMED THAT THE DEVICE IS NOW FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842679 ↗
• InjuryAug 7, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING A BREVERA BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE DEVICE DISPLAYED IMAGE CAPTURE ERRORS AND PROMPTS TO USE "SINGLE CHAMBER MODE." IT IS REPORTED THAT THE NEEDLE HAD ALREADY BEEN INSERTED INTO THE PATIENT'S BREAST AT THE TIME THAT THE ERRORS OCCURRED, DESPITE PASSING SET-UP TESTING PRIOR TO STARTING THE PROCEDURE. THE USER REPORTS THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE; HOWEVER, A SECOND INCISION WAS REQUIRED IN ADDITION TO THE SITUATION CAUSING PATIENT ANXIETY. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE AND FOUND SOFTWARE INCOMPATIBILITY. THE FSE IN COLLABORATION WITH HOLOGIC TECHNICAL SUPPORT LOADED SOFTWARE TO THE SYSTEM AND CORRECTED SOME SOFTWARE SETTINGS IN ORDER TO RESOLVE THE ISSUE. THE FSE CONFIRMED THAT THE DEVICE IS NOW OPERATING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Anxiety

  MAUDE report 22741883 ↗
• InjuryAug 4, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A BREVERA BIOPSY PROCEDURE ON (B)(6) 2025, THE USER EXPERIENCED A SYSTEM ERROR IN WHICH THE DEVICE WAS ARMED BUT DID NOT APPEAR IN A VALID STATE. IT IS REPORTED THAT THE USER ATTEMPTED TO CLEAR THE ERROR, WHICH WAS UNSUCCESSFUL; THEREFORE, THE PATIENT'S PROCEDURE WAS ABORTED AFTER THE NEEDLE HAD ALREADY BEEN INSERTED INTO THE PATIENT'S BREAST. A HOLOGIC TECHNICAL SUPPORT SPECIALIST HAD THE USER DISCONNECT THE DRIVER FROM THE CONSOLE, RESTART THE PC, RELAUNCH THE APPLICATION AND COMPLETE SEVERAL STEPS TO HELP THE DEVICE RECOGNIZE THE DRIVER. HOLOGIC TECHNICAL SUPPORT REPORTS THAT THE ERRORS BEGAN TO CLEAR AND ASSISTED THE USER IN REHOMING THE DRIVER, WHICH APPEARED TO RESOLVE THE ISSUE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708088 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025, THAT DURING A BREVERA BREAST BIOPSY PROCEDURE, THE USER RECEIVED AN "IMAGING SYSTEM NOT AVAILABLE" ERROR CODE AFTER SUCCESSFUL SET-UP AND TESTING OF THE DEVICE. IT IS REPORTED THAT THE USER PERFORMED A FULL SHUTDOWN OF THE SYSTEM; HOWEVER, THE ERROR CODE PERSISTED. REPORTING INDICATES THAT THE PATIENT HAD TO BE RESCHEDULED AFTER MEDICATION INJECTION AND SKIN INCISION HAD ALREADY OCCURRED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE EQUIPMENT AND FOUND THAT THE SYSTEM PERFORMED AS EXPECTED WHEN RUNNING MOCK TEST PATIENTS. THE FSE REPORTS THAT THE SYSTEM MEETS MANUFACTURER SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559446 ↗
• InjuryJun 9, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING A BREVERA PROCEDURE, AN ERROR DISPLAYED ON THE BREVERA DEVICE AFTER THE NEEDLE HAD BEEN INSERTED INTO THE PATIENT. THE CUSTOMER WAS UNABLE TO CLEAR THE DISPLAYED ERROR, AND THE SYSTEM WOULD NOT IMAGE OR ACQUIRE TISSUE. THE PROCEDURE WAS STOPPED, AND THE PATIENT WAS RESCHEDULED, WHICH WILL REQUIRE A NEW INCISION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22171425 ↗
• InjuryJun 9, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING A BREVERA PROCEDURE, AN ERROR DISPLAYED ON THE BREVERA DEVICE AFTER THE NEEDLE HAD BEEN INSERTED INTO THE PATIENT. THE CUSTOMER WAS UNABLE TO CLEAR THE DISPLAYED ERROR, AND THE SYSTEM WOULD NOT IMAGE OR ACQUIRE TISSUE. THE PROCEDURE WAS STOPPED AND THE PATIENT WAS RESCHEDULED, WHICH WILL REQUIRE A NEW INCISION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22171400 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING A BREVERA PROCEDURE, THE USER EXPERIENCED AN IMAGING SYSTEM ERROR, AND THE X-RAY WENT DOWN. IT IS REPORTED THAT THE USER WAS UNABLE TO CLEAR THE ERROR, RESTARTED THE SYSTEM AND COMPLETED ANOTHER QC ON THE NEEDLE; HOWEVER, RECEIVED ANOTHER IMAGING SYSTEM ERROR AS WELL AS A FILTER ERROR. THE USER REPORTS THAT THE SYSTEM WOULD NOT ALLOW THE PROCEDURE TO MOVE FORWARD AND THE PATIENT WAS RESCHEDULED AFTER THE NEEDLE HAD ALREADY BEEN INSERTED. A FIELD ENGINEER WAS DISPATCHED TO ASSESS THE DEVICE BUT WAS UNABLE TO REPRODUCE THE ERROR. THE FIELD ENGINEER UTILIZED A TEST NEEDLE AND WAS ABLE TO TAKE 12 CONSECUTIVE EXPOSURES, AND THE SYSTEM PASSED THE NEEDLE TEST. THE FIELD ENGINEER CONCLUDED THAT THE SYSTEM HAD A DISCONNECT WITH THE CORLUMINA AND A SHUTDOWN WITH POWER OFF FOR MORE THAN A FEW MINUTES MADE IT SO THAT THE SYSTEM WAS ABLE TO RE-ESTABLISH A LINK ONCE POWER WAS RESTORED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169551 ↗
• InjuryJun 2, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2025, A DEVICE ERROR OCCURRED AFTER THE NEEDLE WAS INSERTED INTO THE PATIENT. THE CUSTOMER REPORTS THAT THEY WERE UNABLE TO CLEAR THE ERROR AND THE PATIENT HAD TO BE RESCHEDULED. IT WAS REPORTED THAT AFTER THE PROCEDURE, THE CUSTOMER WAS ABLE TO CLEAR THE ERROR BY HOLDING DOWN THE FIRE BUTTON WITH THE DRIVER DISCONNECTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126721 ↗
• InjuryMay 28, 2025Failure to Obtain Sample; Insufficient Device Problem Information; Failure to Obtain Sample; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2025, THE CUSTOMER COLLECTED 12 SPECIMEN CORES WITH THE BIOPSY NEEDLE; HOWEVER, WHEN IT WAS OPENED, ONLY 2 CORES WERE PRESENT. IT IS REPORTED THAT THE SYSTEM WAS IMAGING DURING THE PROCEDURE. A FIELD ENGINEER WAS DISPATCHED TO ASSESS THE DEVICE AT WHICH TIME A VACUUM TEST WAS RUN AND IT WAS CONFIRMED TO BE WITHIN SPECIFICATIONS. ADDITIONALLY, A MOTOR ACCURACY TEST WAS COMPLETED. THE FIELD ENGINEER VERIFIED THAT THE SYSTEM MEETS MANUFACTURER SPECIFICATIONS. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097465 ↗
• InjuryMay 27, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT MID- BREVERA PROCEDURE ON (B)(6) 2025, THE BREVERA DEVICE WOULD NOT FIRE. IT IS REPORTED THAT THE NEEDLE WAS DISMOUNTED, AND THE DEVICE WAS POWERED DOWN AND UNPLUGGED FOR 2 MINUTES. THE CUSTOMER WAS ABLE TO RESUME NORMAL OPERATION OF THE DEVICE AND COMPLETE THE PROCEDURE; HOWEVER, THE PATIENT REQUIRED A SECOND INCISION TO DO SO. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091546 ↗
• InjuryMar 17, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A SELENIA PROCEDURE ON (B)(6) 2025, THE FOOT PEDAL WOULD NOT ENGAGE TO BEGIN CUTTING. SERVICE WAS CALLED AND THE FOOT PEDAL WAS REPLACED AND SOFTWARE WAS RELOADED. MULTIPLE NEEDLES WERE TESTED TO ENSURE THAT THE MACHINE WAS FUNCTIONING CORRECTLY. AN ADDITIONAL INCISION WAS REQUIRED INTO THE PATIENT´S SKIN. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21626741 ↗
• InjuryFeb 20, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A BREVERA PROCEDURE ON (B)(6) 2025, AN ERROR POPPED DURING THE EXAM AND COULD NOT COMPLETE IT. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND IT WAS DETERMINED THAT THEY DID NOT SET THE SYSTEM TO STANDBY PRIOR TO THE PROBE BEING REMOVED. THIS CAUSED THE PROBE TO BE IN AN INVALID STATE. THE FE WALKED THE CUSTOMER THROUGH THE PROCESS OF DISCONNECTING THE DRIVER AND SHUTTING THE SYSTEM DOWN AND RESTARTED THE SYSTEM. A FOLLOW UP WITH THE CUSTOMER REPORTED THAT NO INJURY WAS REPORTED AND NO MEDICAL INTERVENTION REQUIRED BUT THE PROCEDURE COULD NOT BE COMPLETED AND THE PATIENT WAS GOING TO BE RESCHEDULED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428417 ↗
• InjuryDec 9, 2024Adverse 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) 2024, THE SYSTEM MADE A NOISE AND NO SAMPLES WERE BEING OBTAINED ONLY SALINE SOLUTION WAS OBSERVED IN THE FILTER. THERE WAS NO ISSUE WITH THE TUBING, THE PATIENT WAS RESCHEDULED FOR A NEW PROCEDURE. THE SYSTEM WAS EXAMINED BY A FIELD ENGINEER AND WAS UNABLE TO VERIFY THE CUSTOMER COMPLAINT. A NEW NEEDLE WAS USED AS THE PREVIOUS HAD BEEN DISCARDED, THE FE WAS ABLE TO TAKE SAMPLES USING HAM AND IT WOULD TAKE A SAMPLE AND VERIFIED THAT THE IMAGES WERE CORRECTLY FUNCTIONING. THUS, NO PROBLEM COULD BE CONFIRM. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879984 ↗
• InjuryDec 5, 2024Adverse 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) 2024, THE SYSTEM DISPLAYED ERRORS RELATED TO THE DRIVER AND VACUUM ISSUES AND THE PROCEDURE HAD TO BE ABORTED WHILE THE NEEDLE WAS INSIDE THE BREAST. PATIENT WAS RESCHEDULED FOR A NEW PROCEDURE AND PAIN MEDICATION WAS ADMINISTERED. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND COULD NOT REPLICATE THE ISSUE. THE DRIVER CODES WERE UPDATED AND THE SETTINGS TO SUPPORT RECOMMENDATIONS. SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852010 ↗
• MalfunctionOct 31, 2024Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON OCTOBER 3 A BIOPSY PROCEDURE WAS PERFORMED WITH A BREVERA SYSTEM AND DURING THE PROCEDURE THE TISSUE GOT STUCK IN THE TUBING AND SALINE WAS NOT FLOWING. THE DOCTOR THOUGHT IT WAS NEEDLE BUT THEY HAVE GONE THROUGH MANY DIFFERENT NEEDLES AND THE ISSUE PERSISTED. THE DOCTOR WAS ABLE TO GET SOME TISSUE AND SENT IT TO THE LABORATORY, ALTHOUGH THE DOCTOR RESCHEDULED THE PATIENT FOR ANOTHER BIOPSY, AS THEY COULDN'T GET ANY CALCIFICATIONS. A FIELD ENGINEER EXAMINED THE DEVICE, TESTED THE SUCTION AND FOUND THAT IT WAS WORKING PROPERLY. THEREFORE, NO DEVICE MALFUNCTION WAS FOUND. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582818 ↗
• InjuryOct 4, 2024Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6), A BIOPSY PROCEDURE WAS PERFORMED AND DURING THE PROCEDURE, THE FIRST NEEDLE WAS WORKING BUT THE DOCTOR MISSED TISSUE AND HAD ALREADY REMOVED, THEREFORE, A SECOND NEEDLE WAS USED. WHILE THE DOCTOR WAS TESTING THE NEEDLE IT MADE A GRINDING NOISE. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS RESCHEDULED FOR ANOTHER BIOPSY PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371973 ↗
• InjuryAug 7, 2024Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON JULY 23, DURING A BIOPSY PROCEDURE, WHILE THE NEEDLE WAS IN THE BREAST AN IMAGING SYSTEM ERROR OCCURRED AND THE STAFF WAS UNABLE TO CLEAR WITH A FULL SHUTDOWN. NO SAMPLING WAS RETRIEVED AND THE PATIENT WILL BE RESCHEDULED. A FIELD ENGINEER EXAMINED THE UNIT AND FOUND THE ERROR THAT WAS DESCRIBED, THE FIELD ENGINEER REMOVED COVERS AND RESEATED ALL CORLUMINA CONNECTIONS, BOOTED THE SYSTEM, AND COMPLETED START-UP TESTS. NO FURTHER ERRORS WERE FOUND. THE FIELD ENGINEER VERIFIED REPAIR FIXED THE REPORTED ISSUE. THE SYSTEM MEETS MANUFACTURER SPECIFICATIONS ON JULY 23. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19932870 ↗
• InjuryMay 22, 2024Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON APRIL 29, A BREVERA PROCEDURE WAS PERFORMED, AND WHILE DOING A BREAST BIOPSY THE RADIOLOGIST WENT TO FIRE THE NEEDLE AND THE DEVICE WOULD NOT FIRE. THE STAFF CHANGED THE NEEDLE AND REBOOTED THE SYSTEM AND IT STILL WOULD NOT FIRE. IT ENDED UP BEING THE BREVERA DEVICE AND NOT THE NEEDLES. THE PATIENT WAS BROUGHT IN LATER IN THE WEEK ONCE THE DEVICE WAS REPLACED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371286 ↗
• InjuryApr 8, 2024Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6) A BREVERA PROCEDURE WAS PERFORMED, AND DURING THE PROCEDURE, A DRIVER ERROR OCCURRED, IT TOOK TWO PUNCTURES TO THE SKIN AND 3 NEEDLES TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061321 ↗

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.