ATEC SAPPHIRE 100Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 15420045504028), received between Oct 27, 2020 and Jul 30, 2026 — classified as 21 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (12 reports).

4 other recalls cover devices cleared under the same FDA submission (K042290); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Suction Failure

  It was reported that during a breast biopsy on July 8, 2026 that "the suction stopped working" and "Needle fired and specimen was attempted. No specimen retrieved or taken due to no suction". The procedure was aborted and the patient required an additional biopsy procedure. Customer outreach confirmed "no additional harm was done to the patient or user", "The patient didn't require any additional medical or surgical intervention." that day, but "The biopsy was rescheduled and done the following week with a different needle". No further information is available at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50091413 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE ON (B)(6) 2026, USING AN ATEC SAPPHIRE 100 SYSTEM, THE USER REPORTED "DURING CLINICAL OPERATIONS TODAY THE DOCTOR NOTICE THAT THE SAMPLES SIZE ARE SMALLER THEN USUAL." IT WAS FURTHER REPORTED THAT A PATIENT "HAD TO BE CLIPPED TWICE USING A DIFFERENT NEEDLE FOR EXAMINATION COMPLETION." INJURY MDR IS BEING SUBMITTED DUE TO THE ADDITIONAL SURGICAL INTERVENTION. A HOLOGIC CLINICAL ACCOUNT MANAGER (CAM) VISITED THE CUSTOMER SITE ON (B)(6) 2026, AND RAN TESTS ON THE ATEC SYSTEM IN CONJUNCTION WITH A CUSTOMER SITE TECHNICIAN. THE CAM FOUND THE ATEC SYSTEM TO BE WORKING AS INTENDED. THE CAM FURTHER REPORTED THAT THE USER SITE TECHNICIANS "USUALLY DON¿T PERFORM THE FIRST STEP OF THE ATEC ¿SET UP¿ AND I INSTRUCTED THEM TO DO SO GOING FORWARD. I ALSO THINK THAT MAKING SURE THE RADIOLOGIST CONTINUOUSLY KEEPS THEIR FOOT ON THE FOOT PEDAL TO KEEP THE VACUUM¿S MOMENTUM BUILDING WILL HELP WITH THE TISSUE CORE SIZES AS WELL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409968 ↗
• InjuryJan 27, 2026Failure to Obtain Sample

  IT WAS REPORTED BY THE USER SITE THAT DURING AN ATEC SAPPHIRE PROCEDURE ON (B)(6) 2026, "WE HAD THE RED LIGHT AGAIN AND THE SYSTEM WAS REALLY LOUD AND VIBRATING A LOT. WE WERE NOT ABLE TO COMPLETE THE BIOPSY BECAUSE THE VACUUM WAS NOT WORKING." THE USER LATER CLARIFIED THAT "THE RADIOLOGIST DID TWO ROUNDS OF SAMPLING, AFTER THE SECOND ROUND HE DECIDED HE WANTED TO DO ANOTHER ROUND. DURING THIS TIME IS WHEN THE SYSTEM WENT DOWN. THE PROCEDURE WAS 80% COMPLETE BUT WE DID NOT GET AS MUCH TISSUE AS WE WANTED ON THE THIRD ROUND OF SAMPLING." NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193548 ↗
• InjuryJan 6, 2026Noise, Audible

  IT WAS REPORTED THAT DURING AN ATEC SAPPHIRE BIOPSY PROCEDURE ON (B)(6) 2025, THE "DEMO ATEC FAILED DURING A PROCEDURE," RESULTING IN THE PROCEDURE BEING ABORTED AFTER THE NEEDLE HAD ALREADY BEEN INSERTED INTO THE PATIENT. ADDITIONALLY, IT IS REPORTED THAT "THE PATIENT EXPERIENCED PAIN DUE TO THE RADIOLOGIST NOT BEING ABLE TO HEAR THE BEEP NOTIFYING THE END OF A CUTTING CYCLE. THIS RESULTED IN THE POSSIBILITY THAT THE RADIOLOGIST ROTATED THE CANULA DURING A CUTTING CYCLE." IT IS REPORTED THAT THE USER HAS RECEIVED A NEW ATEC UNIT. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 23979473 ↗
• InjuryDec 22, 2025Suction Problem; Suction Problem

  IT WAS REPORTED BY THE USER SITE ON (B)(6) 2025, THAT "OUR ATEC DOES NOT HAVE ADEQUATE SUCTION. DOCTORS ARE NEEDING TO TAKE ADDITIONAL TISSUE SAMPLES DURING AT LEAST 4 RECENT PROCEDURES. NO ERROR LIGHTS ON SYSTEM, HANDPIECES FROM DIFFERENT LOTS USED. ALL PROCEDURES COMPLETED SUCCESSFULLY, 2 TOOK LONGER THAN EXPECTED, FILTER WAS IMAGED ON DIFFERENT SYSTEM AND THEN ADDITIONAL CORES WERE COLLECTED." IT IS REPORTED THAT ADDITIONAL TISSUE SAMPLES WERE REQUIRED FOR AT LEAST FOUR PATIENT PROCEDURES; THEREFORE, THIS IS BEING REPORTED DUE TO ADDITIONAL MEDICAL/SURGICAL INTERVENTION. THE USER SITE WAS PROVIDED WITH A REPLACEMENT DEVICE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871326 ↗
• InjuryMay 6, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) 2025, THE CUSTOMER REPORTED THAT THERE WAS NOT ENOUGH SUCTION AND REQUIRED TAKING SEVERAL SAMPLES AND NOT ENOUGH. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972570 ↗
• InjuryFeb 4, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN EVIVA PROCEDURE ON (B)(6) 2024, THE DEVICE FAILED TO SAMPLE THE TISSUE. THE BIOPSY WAS CANCELED DUE TO BEING UNABLE TO OBTAIN THE SPECIMENS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305309 ↗
• InjuryJan 10, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE, THE SUCTION WAS NOT FUNCTIONING CORRECTLY AND AN ERROR WAS SHOWN IN THE CONSOLE. PATIENT HAD TO BE TAKEN TO ANOTHER ROOM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SECOND DEVICE BUT A SECOND INCISION WAS REQUIRED. NO INJURY TO THE PATIENT REPORTED AND NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: Laceration(s)

  MAUDE report 21129855 ↗
• InjuryNov 13, 2024Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6) DURING AN ATEC PROCEDURE THE CUSTOMER REPORTED LOSING SUCTION IN THE MIDDLE OF AN MRI BIOPSY. THE DOCTOR COULD NOT CONTINUE WITH THE BIOPSY. CUSTOMER WAS UNSURE IF THE PATIENT WILL BE RESCHEDULED OR NOT. HOLOGIC DID MULTIPLE ATTEMPTS TO OBTAIN INFORMATION NO RESPONSE. CUSTOMER REPORTED THAT THE SUCTION WAS NOT FUNCTIONING CORRECTLY AND THAT THE WATER WAS NOT BEING BROUGHT TO THE CANISTER. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675659 ↗
• InjuryOct 4, 2024Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON OCTOBER 1, THAT TWO BIOPSY PROCEDURES WERE PERFORMED WITH AN ATEC SAPPHIRE CONSOLE, AND ON BOTH PROCEDURES SUCTIONS WAS LOST DURING THE PROCEDURE. NO ERROR LIGHTS WERE SEEN, GETTING REDUCED SUCTION DURING FIRST PROCEDURE WHILE CUTTING FINAL CORE, THEN NO SUCTION FOR LAVAGE. DURING SECOND PROCEDURE, SYSTEM COMPLETED SETUP, NEEDLE INSERTED INTO PATIENT, COMPLETED CUTTING CYCLE, NO TISSUE SAMPLES FOUND IN CANISTER OR IN TUBING. NO SUCTION WHEN TRYING TO LAVAGE TO RETRIEVE ANY SAMPLES. FIRST PROCEDURE COMPLETED SUCCESSFULLY, 2ND PROCEDURE RESCHEDULED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372025 ↗
• InjuryJul 12, 2024Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) 2024, DURING THE BIOPSY THE EQUIPMENT STOPPED SAMPLING SO THEY CHANGED EVERYTHING AND THEY COULDN´T DO ANYTHING BUT POWER UP. A SECOND ATEC CONSOLE WAS USED AND THE BIOPSY WAS ABLE TO BE COMPLETED. A SECOND INCISION WAS REQUIRED. NO ADVERSE EFFECTS OR ADDITIONAL TREATMENT WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735120 ↗
• InjuryMar 6, 2024Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6), AN ATEC PROCEDURE WAS PERFORMED, AND DURING THE PROCEDURE, THERE WAS A LOSS OF SUCTION. THE PHYSICIAN TRIED MULTIPLE NEEDLES AND CANISTERS AND CHECKED ALL CONNECTIONS, BUT ISSUES PERSISTED. THIS FAILED DURING A PROCEDURE WHERE THE PATIENT WAS ALREADY CUT AND READY. PATIENT IS RESCHEDULED FOR ANOTHER PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18845484 ↗
• InjuryJan 15, 2024Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6) DURING AN ATEC PROCEDURE THE TECH HEARD A LEAK DURING THE PROCEDURE AND THE CORES WERE TOO SMALL FOR DIAGNOSTIC USE. SYSTEM WAS REBOOTED AND THE NEEDLE REINSERTED AND THE PROCEDURE COULD NOT BE COMPLETED. SYSTEM WAS EXAMINED AND PASSED ALL TESTS, NO SUCTION ISSUES FOUND. PATIENT WILL NEED TO RETURN FOR 2ND PROCEDURE TO OBTAIN THE SAMPLES. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18511140 ↗
• InjuryOct 6, 2023Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ATEC SAPPHIRE PROCEDURE ON (B)(6) 2023, WHILE THE NEEDLE WAS INSIDE THE BREAST, THE CUTTER WOULD NOT TURN ON AND SPIN. THE HANDPIECE AND CANISTER WERE SWITCHED AND THE ISSUE PERSISTED. THE PATIENT HAD TO BE RESCHEDULED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17890116 ↗
• InjurySep 8, 2023Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6) 2023 AN ATEC SAPPHIRE WAS USED DURING A PROCEDURE AND THE SYSTEM REDUCED SUCTION. THE SYSTEM WILL PASS SETUP, GET LESS SUCTION WHEN STARTING. TECHS HAVE SWITCHED OUT HANDPIECES, NO CHANGE. AFTER THE SYSTEM WORKED AGAIN THE DOCTOR HAD TO PERFORM AN ADDITIONAL INCISION TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17711155 ↗
• MalfunctionJun 23, 2023Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) 2023, THE SYSTEM WAS NOT PULLING BACK SAMPLES. ONE PROCEDURE WAS ABORTED AFTER INCISING AND THE PATIENT HAD TO BE RESCHEDULED. ALL TROUBLE SHOOTING PERFORMED INCLUDING REPLACING THE CANNISTER PRIOR TO CHANGING THE NEEDLE AND SALINE BAG. TESTING OF SECOND NEEDLE SALINE WOULD NOT APPEAR AT THE END OF THE NEEDLE. THE TECHNICIAN COULD NOT FEEL VACUUM WITH HER THUMB ON THE CANNISTER TUBING. PATIENT WAS RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17194335 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON MAY 9TH AN ATEC PROCEDURE WAS DONE AND DUE TO AN ISSUE WITH THE LAVAGE FUNCTION ON THE SYSTEM, THE PATIENT DEVELOPED A LARGE HEMATOMA. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hematoma

  MAUDE report 16955936 ↗
• InjuryMay 18, 2023Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON MAY 10TH, AN ATEC SAPPHIRE PROCEDURE WAS PERFORMED THE SALINE FLOW WAS REDUCED AND THE CORES TAKEN WERE VERY SMALL AND SLOW TO REACH THE CANISTER. NO SALINE FLOW WHEN ATTEMPTING TO TAKE SAMPLES. THE PROCEDURE WAS NOT COMPLETED, PATIENT WAS RESCHEDULED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16954832 ↗
• InjuryApr 11, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED ON (B)(6), THAT THE SYSTEM OVERHEATED DURING A PROCEDURE, THE PATIENT HAD AN INCISION ALREADY DONE AND HAD TO BE RESCHEDULED FOR A NEW PROCEDURE DUE TO THE SYSTEM OVERHEATING, WHICH WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16715629 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON FEBRUARY 16TH, A BIOPSY PROCEDURE WAS PERFORMED. WHILE THE DOCTOR WAS TAKING THE BIOPSY THE SYSTEM WAS NOT TAKING THE LIDOCAINE AND THEY WERE NOT ABLE TO FINISH THE PROCEDURE AND HAD TO RESCHEDULE FOR A NEW PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16567647 ↗
• MalfunctionFeb 10, 2023Suction Failure; Suction Failure

  IT WAS REPORTED THAT ON (B)(6) THE ATEC SAPPHIRE PROCEDURE WAS PERFORMED AND THE UNIT WILL NOT SUCTION OR LAVAGE. IT FAILED DURING A PROCEDURE TODAY. THE PROCEDURE HAD TO BE CANCELED. THE PATIENT WAS RESCHEDULED, AND ADDITIONAL STEREO SCOUT IMAGING AND LIDOCAINE WAS GIVEN FOR THE REPEAT PROCEDURE. NO INJURIES WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16352046 ↗
• MalfunctionSep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) DURING AN ATEC PROCEDURE THE CONSOLE COULD NOT FIRE A CUT STROKE WITH THE PEDAL OR TEST BUTTON WHEN THE NEEDLE WAS INSIDE THE BREAST. THE PROCEDURE COULD NOT BE COMPLETED AND HAD TO BE RESCHEDULED UNTIL A NEW MACHINE CAME IN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15507351 ↗
• MalfunctionSep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AUGUST 30TH DURING AN ATEC PROCEDURE THE CONSOLE COULD NOT FIRE A CUT STROKE WITH THE PEDAL OR TEST BUTTON WHEN THE NEEDLE WAS INSIDE THE BREAST. THE PROCEDURE COULD NOT BE COMPLETED AND HAD TO BE RESCHEDULED UNTIL A NEW MACHINE CAME IN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15507052 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN ATEC PROCEDURE, THE PHYSICIAN COULD NOT OBTAIN SAMPLES IN THE MIDDLE OF THE PROCEDURE. AND THE PROCEDURE HAD TO BE RESCHEDULED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15175007 ↗
• InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS THE FIRST OF TWO REPORTS RELATED TO ONE EVENT. THE SECOND REPORT IS FILED UNDER 1222780-2020-00143. IT WAS REPORTED THAT DURING THE BIOPSY, AIR WAS PUSHED INTO THE BREAST AND IT TRAVELED UP TOWARD THE PATIENT NECK. THE PROCEDURE WAS ABORTED. AN X-RAY WAS PERFORMED BUT CAME BACK UNREMARKABLE. THE BIOPSY WAS NOT COMPLETED. NO ADDITIONAL DETAILS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10744423 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042290. One submission often covers many models, so check the product and lot details in each record.

• Z-2285-2010 · Aug 11, 2010 · Terminated
  Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile, Hologic, Inc. 6100 Technology Center Drive Indianapolis, IN. The handpiece is inserted i
• Z-1160-2010 · Feb 1, 2010 · Terminated
  ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part number 0909-12), Rx, Sterile, Suros Surgical Systems, Inc. 6100 Technology Center DR. India
• Z-0275-2009 · Sep 22, 2008 · Terminated
  ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece, sterile, Hologic, Inc., Indianapolis, IN; Model number ATEC 1212-20. Intended for partial or complete rem
• Z-0362-2007 · Dec 15, 2006 · Terminated
  Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposab