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ATEC 0912-20Recalls & reported problems

Hologic, Inc. · 9G (3.7MM) X 12CM, 20MM HANDPIECE · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Hologic ATEC biopsy instrument is a handheld breast biopsy probe used to remove tissue samples. Reports mostly describe the tip or internal parts breaking apart during a procedure, sometimes leaving pieces of material in the patient, and samples that could not be collected; a few mention suction stopping mid-procedure so the biopsy could not be finished. There are 37 reports, with9 injuries and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
32
Deaths reported
0
Injuries reported
9
Recalls naming it
0

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 15420045504868), received between Jun 24, 2024 and Sep 21, 2026 — classified as 9 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (20 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 2 reportsOct 2024: 4 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 4 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 2 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 6 reportsDec 2025: 3 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 3 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520266
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Fragmentation20
  • Adverse Event Without Identified Device or Use Problem8
  • Failure to Obtain Sample3
  • Clumping in Device or Device Ingredient1
  • Insufficient Device Problem Information1
  • Material Disintegration1

Patient problems

  • No Clinical Signs, Symptoms or Conditions29
  • Device Embedded In Tissue or Plaque1
  • Foreign Body In Patient1
  • Hypersensitivity/Allergic reaction1

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 21, 2026Material Fragmentation

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50845987 ↗
  • InjuryJul 27, 2026Material Fragmentation

    The customer reported via Product Feedback Form - 393816 (1 of 2), that a moon shaped particle ("foreign object debris" (FOD)), was inside the patient's biopsy sample. No patient or user harm was reported. No further information is available at this time.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50045679 ↗
  • InjuryJun 1, 2026Failure to Obtain Sample

    IT WAS REPORTED THAT DURING A ATEC BREAST BIOPSY PROCEDURE ON (B)(6) 2026, THE USER EXPERIENCED ISSUES WITH THE DEVICE SUCTION "WHEN APPROXIMATELY ONE-THIRD OF THE NODULE REMAINED." IT IS REPORTED THAT THE DISPOSABLE NEEDLE WAS REPLACED; HOWEVER, THE USER REPORTS THE PROCEDURE STILL COULD NOT BE CONTINUED. IT IS REPORTED THAT NO ERROR MESSAGES WERE OBSERVED AND A REQUEST FOR SERVICE WAS SUBMITTED. THE USER SITE FURTHER REPORTS THAT UPON THE ARRIVAL OF THE ENGINEER, THE SYSTEM PASSED THE SELF-TESTING; HOWEVER, "THE SUCTION GENERATED WAS STILL INSUFFICIENT TO SUPPORT COMPLETION OF THE EXCISION BY THE BREAST SURGEON." DUE TO THE REPORTED ISSUE EXPERIENCED BY THE USER, AND THE INABILITY TO COMPLETE THE PROCEDURE UTILIZING THE ATEC DEVICE, THE SURGICAL PLAN WAS CHANGED TO AN OPEN PROCEDURE. IT IS REPORTED THAT THE HOSPITAL CONTACTED HOLOGIC IMMEDIATELY. HOLOGIC THEN NOTIFIED THE DISTRIBUTOR TO PROVIDE A BACKUP UNIT AS SOON AS POSSIBLE, AND A FIELD SERVICE ENGINEER WAS ARRANGED TO PERFORM AN ON-SITE INSPECTION AND REPAIR, INCLUDING REPLACEMENT OF THE PROBE AND INSPECTION OF THE TUBING. SUBSEQUENTLY, A HOLOGIC FIELD ENGINEER PROVIDED ON-SITE SUPPORT DURING THE PROCEDURE, AND THE DEVICE FU

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25349192 ↗
  • MalfunctionMar 30, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT DURING AN ATEC BREAST BIOPSY PROCEDURE ON (B)(6), 2025, "A VERY SMALL, FOREIGN OBJECT" WAS FOUND INSIDE THE ATEC NEEDLE BASKET. IT IS FURTHER REPORTED THAT THE MATERIEL "BECOMES TRAPPED IN THE TISSUE SAMPLE." IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT HARM WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24736873 ↗
  • MalfunctionMar 30, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT DURING AN ATEC BREAST BIOPSY PROCEDURE ON (B)(6) 2025, "A VERY SMALL, FOREIGN OBJECT" WAS FOUND INSIDE THE ATEC NEEDLE BASKET. IT IS FURTHER REPORTED THAT THE MATERIEL "BECOMES TRAPPED IN THE TISSUE SAMPLE." IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT HARM WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24736583 ↗
  • MalfunctionMar 19, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AFTER AN ATEC BREAST BIOPSY PROCEDURE ON (B)(6), "MAMMOGRAPHIC IMAGING OF THE EXCISED SPECIMENS SHOWED ADDITIONAL HIGH-DENSITY SHADOWS. TWO WHITE SOLID PIECES WERE FOUND IN THE BIOPSY SPECIMEN." NO PATIENT HARM WAS REPORTED. NO FURTHER DETAILS ARE CURRENTLY AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24642871 ↗
  • MalfunctionDec 4, 2025Material Fragmentation; Material Fragmentation

    IT WAS REPORTED BY THE DEALER THAT DURING AN ATEC BIOPSY PROCEDURE ON (B)(6) 2025, THAT "CALL RECEIVED FROM THE CUSTOMER THAT THEY ARE SEEING PARTICLES, AFTER THE BIOPSY PROCEDURE. WE WENT THERE AND ISOLATED THE PARTICLE. IT IS A HARD MATERIAL PROBABLY SOME PART OF THE NEEDLE." IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO HARM TO THE PATIENT OR USER WAS REPORTED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23717737 ↗
  • MalfunctionDec 3, 2025Material Fragmentation; Material Fragmentation

    IT WAS REPORTED BY THE DEALER THAT DURING AN ATEC BIOPSY PROCEDURE ON (B)(6) 2025, THAT "CALL RECEIVED FROM THE CUSTOMER THAT THEY ARE SEEING PARTICLES, AFTER THE BIOPSY PROCEDURE. WE WENT THERE AND ISOLATED THE PARTICLE. IT IS A HARD MATERIAL PROBABLY SOME PART OF THE NEEDLE." IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO HARM TO THE PATIENT OR USER WAS REPORTED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23708469 ↗
  • MalfunctionDec 3, 2025Material Fragmentation; Material Fragmentation

    IT WAS REPORTED BY THE DEALER THAT DURING AN ATEC BIOPSY PROCEDURE ON (B)(6) , 2025, THAT "CALL RECEIVED FROM THE CUSTOMER THAT THEY ARE SEEING PARTICLES, AFTER THE BIOPSY PROCEDURE. WE WENT THERE AND ISOLATED THE PARTICLE. IT IS A HARD MATERIAL PROBABLY SOME PART OF THE NEEDLE." IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO HARM TO THE PATIENT OR USER WAS REPORTED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23707493 ↗
  • MalfunctionNov 18, 2025Material Fragmentation; Material Fragmentation

    THE CUSTOMER REPORTED ON (B)(6) 2025, THAT THERE WAS THE PRESENCE OF GREASE ON THE ATEC NEEDLE, SPECIFICALLY AT THE DISTAL END NEAR THE COLLECTION CHAMBER. THE CUSTOMER OBSERVED THAT, ON CERTAIN OCCASIONS, THE AMOUNT OF GREASE APPEARS EXCESSIVE, AND EXPRESSED CONCERN THAT THIS MAY INHIBIT THE PROPER DEPLOYMENT OF THE MARKER. FURTHER INVESTIGATION FOUND THAT THE MARKER WAS SUCCESSFULLY DEPLOYED IN ALL AFFECTED CASES. IT WAS FURTHER REPORTED THAT IN ADDITION TO EXCESSIVE GREASE, FOREIGN MATERIAL WAS OBSERVED WHEN IMAGING THE BIOPSY SAMPLE. IT IS REPORTED THAT THE FOREIGN MATERIAL IS SOMETIMES COVERING THE MICRO CALCIFICATIONS. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23583934 ↗
  • MalfunctionNov 18, 2025Material Fragmentation; Material Fragmentation

    THE CUSTOMER REPORTED ON (B)(6) 2025, THAT THERE WAS THE PRESENCE OF GREASE ON THE ATEC NEEDLE, SPECIFICALLY AT THE DISTAL END NEAR THE COLLECTION CHAMBER. THE CUSTOMER OBSERVED THAT, ON CERTAIN OCCASIONS, THE AMOUNT OF GREASE APPEARS EXCESSIVE, AND EXPRESSED CONCERN THAT THIS MAY INHIBIT THE PROPER DEPLOYMENT OF THE MARKER. FURTHER INVESTIGATION FOUND THAT THE MARKER WAS SUCCESSFULLY DEPLOYED IN ALL AFFECTED CASES. IT WAS FURTHER REPORTED THAT IN ADDITION TO EXCESSIVE GREASE, FOREIGN MATERIAL WAS OBSERVED WHEN IMAGING THE BIOPSY SAMPLE. IT IS REPORTED THAT THE FOREIGN MATERIAL IS SOMETIMES COVERING THE MICRO CALCIFICATIONS. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23583860 ↗
  • MalfunctionNov 18, 2025Material Fragmentation; Material Fragmentation

    THE CUSTOMER REPORTED ON (B)(6) 2025, THAT THERE WAS THE PRESENCE OF GREASE ON THE ATEC NEEDLE, SPECIFICALLY AT THE DISTAL END NEAR THE COLLECTION CHAMBER. THE CUSTOMER OBSERVED THAT, ON CERTAIN OCCASIONS, THE AMOUNT OF GREASE APPEARS EXCESSIVE, AND EXPRESSED CONCERN THAT THIS MAY INHIBIT THE PROPER DEPLOYMENT OF THE MARKER. FURTHER INVESTIGATION FOUND THAT THE MARKER WAS SUCCESSFULLY DEPLOYED IN ALL AFFECTED CASES. IT WAS FURTHER REPORTED THAT IN ADDITION TO EXCESSIVE GREASE, FOREIGN MATERIAL WAS OBSERVED WHEN IMAGING THE BIOPSY SAMPLE. IT IS REPORTED THAT THE FOREIGN MATERIAL IS SOMETIMES COVERING THE MICRO CALCIFICATIONS. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23583753 ↗
  • MalfunctionNov 18, 2025Material Fragmentation; Material Fragmentation

    THE CUSTOMER REPORTED ON (B)(6) , 2025, THAT THERE WAS THE PRESENCE OF GREASE ON THE ATEC NEEDLE, SPECIFICALLY AT THE DISTAL END NEAR THE COLLECTION CHAMBER. THE CUSTOMER OBSERVED THAT, ON CERTAIN OCCASIONS, THE AMOUNT OF GREASE APPEARS EXCESSIVE, AND EXPRESSED CONCERN THAT THIS MAY INHIBIT THE PROPER DEPLOYMENT OF THE MARKER. FURTHER INVESTIGATION FOUND THAT THE MARKER WAS SUCCESSFULLY DEPLOYED IN ALL AFFECTED CASES. IT WAS FURTHER REPORTED THAT IN ADDITION TO EXCESSIVE GREASE, FOREIGN MATERIAL WAS OBSERVED WHEN IMAGING THE BIOPSY SAMPLE. IT IS REPORTED THAT THE FOREIGN MATERIAL IS SOMETIMES COVERING THE MICRO CALCIFICATIONS. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23583695 ↗
  • MalfunctionNov 18, 2025Material Fragmentation; Material Fragmentation

    THE CUSTOMER REPORTED ON (B)(6) 2025, THAT THERE WAS THE PRESENCE OF GREASE ON THE ATEC NEEDLE, SPECIFICALLY AT THE DISTAL END NEAR THE COLLECTION CHAMBER. THE CUSTOMER OBSERVED THAT, ON CERTAIN OCCASIONS, THE AMOUNT OF GREASE APPEARS EXCESSIVE, AND EXPRESSED CONCERN THAT THIS MAY INHIBIT THE PROPER DEPLOYMENT OF THE MARKER. FURTHER INVESTIGATION FOUND THAT THE MARKER WAS SUCCESSFULLY DEPLOYED IN ALL AFFECTED CASES. IT WAS FURTHER REPORTED THAT IN ADDITION TO EXCESSIVE GREASE, FOREIGN MATERIAL WAS OBSERVED WHEN IMAGING THE BIOPSY SAMPLE. IT IS REPORTED THAT THE FOREIGN MATERIAL IS SOMETIMES COVERING THE MICRO CALCIFICATIONS. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23583503 ↗
  • MalfunctionNov 17, 2025Material Fragmentation; Material Fragmentation

    THE CUSTOMER REPORTED ON (B)(6) 2025, THAT THERE WAS THE PRESENCE OF GREASE ON THE ATEC NEEDLE, SPECIFICALLY AT THE DISTAL END NEAR THE COLLECTION CHAMBER. THE CUSTOMER OBSERVED THAT, ON CERTAIN OCCASIONS, THE AMOUNT OF GREASE APPEARS EXCESSIVE, AND EXPRESSED CONCERN THAT THIS MAY INHIBIT THE PROPER DEPLOYMENT OF THE MARKER. FURTHER INVESTIGATION FOUND THAT THE MARKER WAS SUCCESSFULLY DEPLOYED IN ALL AFFECTED CASES. IT WAS FURTHER REPORTED THAT IN ADDITION TO EXCESSIVE GREASE, FOREIGN MATERIAL WAS OBSERVED WHEN IMAGING THE BIOPSY SAMPLE. IT IS REPORTED THAT THE FOREIGN MATERIAL IS SOMETIMES COVERING THE MICRO CALCIFICATIONS. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23572072 ↗
  • MalfunctionOct 17, 2025Material Fragmentation; Adverse Event Without Identified Device or Use Problem; Material Fragmentation; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT DURING AND ATEC PROCEDURE ON (B)(6) 2025, THE USER OBSERVED EXCESSIVE "GREASE" AROUND THE OPENING OF THE TISSUE COLLECTION CHAMBER. IT IS REPORTED THAT THE USER UTILIZED THE DEVICE AND SUCCESSFULLY COMPLETED THE PATIENT PROCEDURE; HOWEVER, OBSERVED A FOREIGN PARTICLE IN THE TISSUE SAMPLE. NO PATIENT OR USER INJURY WAS REPORTED, AND NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23328152 ↗
  • InjuryJul 14, 2025Failure to Obtain Sample; Failure to Obtain Sample

    IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) 2025, THE NEEDLE LOST SUCTION AFTER COMING IN CONTACT WITH THE PATIENT. IT IS REPORTED THAT THE USER DID NOT HAVE A BACK-UP DEVICE TO REPLACE THE NEEDLE THAT LOST SUCTION; THEREFORE, THE PROCEDURE WAS ABORTED AFTER THE SKIN INCISION HAD ALREADY BEEN MADE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22493590 ↗
  • MalfunctionJul 8, 2025Clumping in Device or Device Ingredient; Insufficient Device Problem Information; Clumping in Device or Device Ingredient; Insufficient Device Problem Information

    IT WAS REPORTED ON (B)(6) 2025, THAT DURING AN ATEC PROCEDURE, FOREIGN MATERIAL WAS NOTED TO BE IN THE TISSUE SAMPLE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22441040 ↗
  • InjuryJun 30, 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 PATIENT EXPERIENCED AN ALLERGIC REACTION DURING HER BIOPSY. IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 22358280 ↗
  • MalfunctionJan 28, 2025Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT ON (B)(6) 2024 A PHYSICIAN REPORTED THAT SOMETIMES WHEN PERFORMING A BIOPSY WITH AN ATEC NEEDLE THEY NOTICED A PIECE OF MATERIAL PLASTIC IN BETWEEN THE SPECIMENS. PHYSICIAN PROVIDED A PICTURE IN WHICH IT CAN BE OBSERVED A PLASTIC PARTICLE MIXED ALONG WITH THE SAMPLES. THE PARTICLES WERE ONLY OBSERVED IN THE SAMPLES AND NOT IN THE PATIENTS. NO SAMPLES HAVE BEEN OBSERVED IN THE BREAST OF THE PATIENT. PHYSICIAN REPORTED THAT NO INJURY WAS REPORTED TO PATIENTS NOR USERS. NO OTHER INFORMATION AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21261351 ↗
  • MalfunctionJan 28, 2025Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT ON (B)(6) 2024 A PHYSICIAN REPORTED THAT SOMETIMES WHEN PERFORMING A BIOPSY WITH AN ATEC NEEDLE THEY NOTICED A PIECE OF MATERIAL PLASTIC IN BETWEEN THE SPECIMENS. PHYSICIAN PROVIDED A PICTURE IN WHICH IT CAN BE OBSERVED A PLASTIC PARTICLE MIXED ALONG WITH THE SAMPLES. THE PARTICLES WERE ONLY OBSERVED IN THE SAMPLES AND NOT IN THE PATIENTS. NO SAMPLES HAVE BEEN OBSERVED IN THE BREAST OF THE PATIENT. PHYSICIAN REPORTED THAT NO INJURY WAS REPORTED TO PATIENTS NOR USERS. NO OTHER INFORMATION AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21261345 ↗
  • MalfunctionJan 28, 2025Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT ON (B)(6) 2024 A PHYSICIAN REPORTED THAT SOMETIMES WHEN PERFORMING A BIOPSY WITH AN ATEC NEEDLE THEY NOTICED A PIECE OF MATERIAL PLASTIC IN BETWEEN THE SPECIMENS. PHYSICIAN PROVIDED A PICTURE IN WHICH IT CAN BE OBSERVED A PLASTIC PARTICLE MIXED ALONG WITH THE SAMPLES. THE PARTICLES WERE ONLY OBSERVED IN THE SAMPLES AND NOT IN THE PATIENTS. NO SAMPLES HAVE BEEN OBSERVED IN THE BREAST OF THE PATIENT. PHYSICIAN REPORTED THAT NO INJURY WAS REPORTED TO PATIENTS NOR USERS. NO OTHER INFORMATION AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21261342 ↗
  • MalfunctionJan 28, 2025Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT ON (B)(6) 2024 A PHYSICIAN REPORTED THAT SOMETIMES WHEN PERFORMING A BIOPSY WITH AN ATEC NEEDLE THEY NOTICED A PIECE OF MATERIAL PLASTIC IN BETWEEN THE SPECIMENS. PHYSICIAN PROVIDED A PICTURE IN WHICH IT CAN BE OBSERVED A PLASTIC PARTICLE MIXED ALONG WITH THE SAMPLES. THE PARTICLES WERE ONLY OBSERVED IN THE SAMPLES AND NOT IN THE PATIENTS. NO SAMPLES HAVE BEEN OBSERVED IN THE BREAST OF THE PATIENT. PHYSICIAN REPORTED THAT NO INJURY WAS REPORTED TO PATIENTS NOR USERS. NO OTHER INFORMATION AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21261334 ↗
  • InjuryDec 30, 2024Material Disintegration; Material Disintegration

    IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) 2024, THE PHYSICIAN REPORTED THAT PIECES OF PLASTIC REMAINED BEHIND IN THE BREAST OF THE PATIENT. NO OTHER INFORMATION COULD BE OBTAINED.

    Patient problems: Foreign Body In Patient

    MAUDE report 21035403 ↗
  • MalfunctionOct 30, 2024Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT ON OCTOBER 1ST A PHYSICIAN REPORTED THAT SOMETIMES WHEN PERFORMING A BIOPSY WITH AN ATEC NEEDLE THEY NOTICED A PIECE OF MATERIAL PLASTIC IN BETWEEN THE SPECIMENS. PHYSICIAN PROVIDED A PICTURE IN WHICH IT CAN BE OBSERVED A PLASTIC PARTICLE MIXED ALONG WITH THE SAMPLES. THE PARTICLES WERE ONLY OBSERVED IN THE SAMPLES AND NOT IN THE PATIENTS. PHYSICIAN REPORTED THAT NO INJURY WAS REPORTED TO PATIENTS NOR USERS AND THAT THE LOT NUMBERS WERE NOT AVAILABLE. NO ADDITIONAL INTERVENTION PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20570638 ↗

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

Other INSTRUMENT, BIOPSY devices

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