ATEC PEARLRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 15420045506855), received between Sep 24, 2022 and Jun 1, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Obtain Sample” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE USER THAT PRIOR TO AN ATEC PEARL BIOPSY PROCEDURE ON (B)(6) 2026, "TECH TESTED THE NEEDLE AND EVERYTHING WAS FINE. WHEN THE DOCTOR WOULD DO THE BIOPSY BY PRESSING THE PEDAL, IT WOULD NOT WORK. EVENTUALLY, IT WORKED BUT WHEN THE DOCTOR TOOK HER FOOT OFF THE PEDAL, IT TOOK TWO MORE SAMPLES." NO PATIENT HARM WAS REPORTED; HOWEVER, INJURY MDR IS BEING SUBMITTED DUE TO UNINTENDED ADDITIONAL TISSUE BEING REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350464 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE USER SITE THAT DURING AN ATEC PEARL BREAST BIOPSY PROCEDURE ON (B)(6) 2026, THE "MACHINE KEPT TAKING BIOPSIES EVEN AFTER THE RADIOLOGIST TOOK HER FOOT OFF THE FOOT PEDAL." IT IS FURTHER REPORTED THAT THE DEVICE HAD TO BE TURNED OFF TO PREVENT MORE SAMPLES FROM BEING ACQUIRED. IT IS REPORTED THAT THE BIOMED AT THE USER FACILITY TESTED THE DEVICE WITH A TRAINING NEEDLE AND FOUND THAT IT WOULD NOT FINISH THE CYCLE OF TESTING. ADDITIONALLY, THE USER FACILITY BIOMED REPORTS THAT "I CHECKED ALL THE CONNECTIONS AND THEN CHECKED THE AIRLINES COMING OUT OF THE MACHINE TO THE FOOT PEDAL. I NOTICED THAT THEY WERE KINKED AND TIGHTLY WOUND TO MACHINE." IT IS REPORTED THAT AFTER CORRECTING THE LINES, "THE MACHINE COULD CYCLE AND WAS ABLE TO BE STOPPED EVERY TIME I LIFTED MY FOOT OFF." IT IS REPORTED THAT THE PATIENT COMPLAINED OF PAIN. INJURY MDR IS BEING SUBMITTED DUE TO THE REPORT OF ADDITIONAL TISSUE BEING REMOVED FROM THE PATIENT.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 24954164 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATEC PEARL BREAST BIOPSY PROCEDURE IN (B)(6) 2026, THE USER REMOVED HER FOOT FROM THE BIOPSY PEDAL; HOWEVER, "TWO ADDITIONAL UNNECESSARY SAMPLES OF THE AREA" WERE ACQUIRED. IT IS FURTHER REPORTED THAT UPON INVESTIGATION BY THE USER, "IT WAS NOTED THAT THE AIR HOSES WERE KINKED, CAUSING THE MALFUNCTION." NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24608426 ↗
• InjuryAug 7, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) 2025, THE USER OBSERVED THE "RETEST HANDPIECE" LIGHT FLASHING AFTER TAKING THE FIRST FEW SAMPLES. IT IS REPORTED THAT THIS HAS OCCURRED SEVERAL TIMES AND THE TECH HAS BEEN ABLE TO COMPLETE THE PROCEDURE WITH A DIFFERENT NEEDLE IN THE PAST; HOWEVER, DURING THIS OCCURRENCE, THE PROCEDURE COULD NOT BE COMPLETED, AND THE PATIENT WAS RESCHEDULED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742802 ↗
• InjuryJul 1, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT IS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) 2024, THE USER INDICATES THAT DIFFICULTIES OCCURRED DURING A BREAST BIOPSY. IT IS REPORTED THAT THE SALINE BAG RAN OUT OF SALINE AND THE TECH PROCEEDED TO CHANGE THE SALINE BAG; HOWEVER, WHEN THE SALINE BAG WAS REPLACED, IT DID NOT WORK. THE REPORTER INDICATES THAT THE NEW SALINE BAG DID NOT FLUSH THE SALINE IN THE TUBING; THEREFORE, THE RADIOLOGIST WAS NOT ABLE TO GET ALL THE SPECIMEN OUT OF THE TUBING. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22370981 ↗
• InjuryJan 24, 2025Adverse 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) 2025, THE CUSTOMER REPORTED THAT NO SUCTION WAS OBSERVED, MULTIPLE NEEDLES WERE EXCHANGED AND CHECKED CONNECTIONS, NO EXTRA INCISION WERE PERFORMED. PROCEDURE WAS NOT ABLE TO BE COMPLETED AND THE PROCEDURE WAS RESCHEDULED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21230847 ↗
• InjuryDec 12, 2024Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) 2024, THE SYSTEM HAD REDUCED SALINE FLOW. THE NEEDLE WAS TESTED CORRECTLY. THE LACK OF LAVAGE CAUSED A HEMATOMA IN THE PATIENT´S BREAST. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO ADDITIONAL INCISION WERE MADE. THE CONSOLE WAS RETURNED AND INVESTIGATED IT WAS OBSERVED THAT THE PRESSURE SWITCHES AND AIR MOTOR PRESSURE WERE OUT OF CALIBRATION. A PREVENTIVE MAINTENANCE WAS PERFORMED, CALIBRATED AND TESTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Hematoma

  MAUDE report 20913964 ↗
• MalfunctionSep 24, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN ATEC PROCEDURE A FOOT PEDAL ISSUE OCCURRED DURING THE PROCEDURE THAT CAUSED THE PHYSICIAN UNABLE TO COLLECT SAMPLES SO THE PATIENT HAD TO BE RESCHEDULED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15480784 ↗

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