ATEC SAPPHIRERecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 15420045504295), received between Sep 15, 2022 and Sep 3, 2026 — classified as 16 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Failure to Cycle; Failure to Cut

  The customer reported the device passed setup processes. However, when using the foot switch, the device wouldn't cut normally. The customer reported when holding down the foot switch, the cutting cycle stopped with the trough open after collecting several "[biopsy]" cores. No report of patient or user harm. No further information is available at this time.

  Patient problems: Insufficient Information

  MAUDE report 50591946 ↗
• InjuryJul 27, 2026Failure to Obtain Sample

  The customer reported during a breast biopsy the device experienced a negative pressure failure. The customer also reported that when the cutting command was triggered by the foot pedal, the inner cutter did not operate. As a result, the specimen chamber could not retain the sample, leaving the specimen chamber empty. To successfully obtain a pathological specimen, the procedure was converted from minimally invasive vacuum-assisted biopsy to open excision surgery. The surgical incision was enlarged to complete the lesion sampling. Upon follow up, no further harm was confirmed. No further information available at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50006228 ↗
• InjuryJul 1, 2026Suction Problem

  IT WAS REPORTED DURING A BREAST BIOPSY WITH AN ATEC SAPPHIRE DEVICE ON OR AROUND JUNE 16, 2026 THAT "THE SYSTEM FAILED TO AUTOMATICALLY LAVAGE AND INJECT LIDOCAINE DURING AN MRI PROCEDURE. UNFORTUNATELY, THIS RESULTED IN SEVERE PAIN FOR THE PATIENT AND CAUSED A HEMATOMA." CUSTOMER OUTREACH WAS PERFORMED TO FURTHER CLARIFY ANY REQUIRED INTERVENTIONS, AND IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Breast Discomfort/Pain; Hematoma

  MAUDE report 25676808 ↗
• InjuryApr 22, 2026Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ATEC SAPPHIRE BIOPSY PROCEDURE ON (B)(6) 2026, THE USER EXPERIENCED "LOW SUCTION" AND REPORTS THAT ONLY "A FEW SMALL CORES" WERE RETRIEVED. THE USER REPORTS THAT NO ERROR LIGHTS WERE OBSERVED AND TROUBLESHOOTING WAS ATTEMPTED BY SWITCHING THE HANDPIECE AND CANISTER; HOWEVER, THE ISSUE PERSISTED. ADDITIONAL INFORMATION WAS OBTAINED FROM THE USER SITE, IN WHICH IT WAS REPORTED THAT "THE PROCEDURE WAS COMPLETED WITH THE DEVICE, BUT DUE TO THE INADEQUATE SAMPLES, THE PATIENT HAD TO RETURN FOR A SECOND/REPEAT BIOPSY." NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954787 ↗
• MalfunctionApr 9, 2026Material Frayed

  IT WAS REPORTED THAT DURING AN ATEC SAPPHIRE BREAST BIOPSY PROCEDURE ON (B)(6) 2026, THE USER OBSERVED "THE CORD ATTACHED TO THE FOOTSWITCH ON THE SIDE OF THE DEVICE, THE PLASTIC COATING CRACKED NEAR THE VACUUM AND HAS EXPOSED "WIRES." IT WAS FURTHER REPORTED THAT THE PATIENT PROCEDURE WAS NOT COMPLETED. SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE USER WERE UNSUCCESSFUL. NO PATIENT HARM WAS REPORTED, AND NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831673 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATEC SAPPHIRE PROCEDURE ON (B)(6) 2026, THE USER EXPERIENCED ISSUES WITH THE DEVICE FOOTSWITCH IN WHICH IT WAS REPORTED THAT "WHEN PRESSING THE FOOTSWITCH, IT'S TAKING TWO SAMPLES. IT'S SUPPOSED TO TAKE ONLY ONE." IT IS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. MDR IS BEING SUBMITTED DUE TO THE REPORT OF ADDITIONAL TISSUE SAMPLES BEING ACQUIRED; TWO SAMPLES INSTEAD OF THE INTENDED ONE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24446945 ↗
• InjuryDec 3, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED VIA MEDSUN REPORT (B)(4) THAT DURING AN ATEC BIOPSY PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2025, THE "BIOPSY COMPRESSOR DEVICE FAILED WHILE BIOPSY PROBE WAS INSIDE PATIENT'S BREAST. NOBODY WAS HARMED BUT WAS UNABLE TO COLLECT A SAMPLE DUE TO THE COMPRESSOR ISSUE." NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709103 ↗
• InjuryMay 15, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN ATEC SAPPHIRE PROCEDURE ON (B)(6) THE CUSTOMER REPORTED THAT THEY WERE EXPERIENCING INTERMITTENT ISSUES WITH OBTAINING SAMPLES AND THAT THE SAMPLES WERE SMALL AND THERE WAS A DIFFERENT NOISE. IT WAS CONFIRMED THAT 2 PATIENTS REQUIRED TO BE RESCHEDULED FOR NEW PROCEDURES. THE CONSOLE WAS RETURNED FOR INVESTIGATION AND IT WAS FOUND THAT THE BULKHEAD CONNECTOR WAS REPLACED AND THAT THE PRESSURE SWITCHES AND CUTTER STROKES TIMES NEEDED CALIBRATION, THE BULKHEAD CONNECTOR WAS REPLACED, PREVENTIVE MAINTENANCE WAS PERFORMED, CONSOLE CALIBRATED AND TESTED AND ALL TESTING PASSED. CONSOLE WAS REFURBISHED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031583 ↗
• InjuryMay 15, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN ATEC SAPPHIRE PROCEDURE ON APRIL 17TH THE CUSTOMER REPORTED THAT THEY WERE EXPERIENCING INTERMITTENT ISSUES WITH OBTAINING SAMPLES AND THAT THE SAMPLES WERE SMALL AND THERE WAS A DIFFERENT NOISE. IT WAS CONFIRMED THAT 2 PATIENTS REQUIRED TO BE RESCHEDULED FOR NEW PROCEDURES. THE CONSOLE WAS RETURNED FOR INVESTIGATION AND IT WAS FOUND THAT THE BULKHEAD CONNECTOR WAS REPLACED AND THAT THE PRESSURE SWITCHES AND CUTTER STROKES TIMES NEEDED CALIBRATION, THE BULKHEAD CONNECTOR WAS REPLACED, PREVENTIVE MAINTENANCE WAS PERFORMED, CONSOLE CALIBRATED AND TESTED AND ALL TESTING PASSED. CONSOLE WAS REFURBISHED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031518 ↗
• InjuryMar 25, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) 2025, THE CUSTOMER REPORTED THAT THE SUCTION FROM THE CONSOLE DROPPED AND STOPPED. SAMPLES COULD NOT BE OBTAINED AFTER THE NEEDLE WAS INSIDE THE BREAST AND THE PATIENT HAD TO BE RESCHEDULED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689530 ↗
• InjuryFeb 14, 2025Failure to Obtain Sample; Adverse Event Without Identified Device or Use Problem; Failure to Obtain Sample; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) 2025, THE FOOT PEDAL WAS NOT WORKING CORRECTLY AND COULD NOT PRODUCE A CUT. THUS A PATIENT HAD TO BE RESCHEDULED FOR THE 2ND HALF OF A 2 SITE PROCEDURE. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21384572 ↗
• InjurySep 23, 2024Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6) 2024, A BIOPSY PROCEDURE WAS PERFORMED WITH AN ATEC SAPPHIRE AN AFTER AN INCISION WAS DONE TO THE PATIENT, THE FOOTSWITCH GOT BROKEN, ONE OF THE QUICK CONNECT WAS BROKEN COMPLETELY OFF. HAD TO RESCHEDULE PATIENT FOR TAN OTHER BIOPSY PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20284798 ↗
• InjuryMay 15, 2024Failure to Obtain Sample; Failure to Obtain Sample

  DHR INFO PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323307 ↗
• InjuryJan 4, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2022, AN ATEC PROCEDURE WAS PERFORMED AND THE DEVICE WILL NOT FIRE A CUT STROKE WITH EITHER THE PEDAL OR THE TEST BUTTON. RESTARTING DID NOT RESOLVE IT. THE PATIENT ALREADY HAD AN INCISION DONE AND HAS TO BE RESCHEDULED FOR A NEW PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096513 ↗
• InjuryOct 29, 2022Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6) DURING AN ATEC SAPPHIRE PROCEDURE WAS PERFORMED, AND THE DEVICE LOST SUCTION DURING THE BIOPSY PROCEDURE, AND THE PHYSICIAN IS UNABLE TO CONFIRM IF CALCIFICATIONS WERE RETRIEVED, AND MAY NEED TO REPEAT THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15697165 ↗
• InjuryOct 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON SEPTEMBER 29TH, 2022, AN ATEC SAPPHIRE PROCEDURE WAS PERFORMED, AND THE PHYSICIAN WAS UNABLE TO COMPLETE IT DUE TO LOW SUCTION ON THE SYSTEM DURING THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15694667 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) DURING THE BIOPSY THE LAVAGE DID NOT FUNCTION PROPERLY , THIS ISSUE CAUSED THE PATIENT TO HAVE A HEMATOMA AFTER THE BIOPSY. ADDITIONAL INFORMATION RECEIVED : PATIENT LEFT THE IMAGING CENTER AFTER THE BIOPSY AND NO INJURIES NOR ADDITIONAL INTERVENTION REQUIRED.

  Patient problems: Hematoma

  MAUDE report 15471197 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) DURING THE BIOPSY THE LAVAGE DID NOT FUNCTION PROPERLY , THIS ISSUE CAUSED THE PATIENT TO HAVE A HEMATOMA AFTER THE BIOPSY. ADDITIONAL INFORMATION RECEIVED : PATIENT LEFT THE IMAGING CENTER AFTER THE BIOPSY AND NO INJURIES NOR ADDITIONAL INTERVENTION REQUIRED. NO OTHER INFORMATION RECEIVED.

  Patient problems: Hematoma

  MAUDE report 15433577 ↗

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