ATEC 0914-20MRRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 15420045504899), received between May 5, 2021 and Sep 21, 2026 — classified as 10 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Contamination” (4 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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Contamination

  It was reported by the user site that the lot was "deemed contaminated with black specks on spike that is inserted into patient's saline." The issue was identified prior to patient use and the device was removed from service. No patient or user harm was reported, and no additional medical or surgical intervention was required.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842332 ↗
• InjurySep 21, 2026Failure to Obtain Sample

  It was reported by the user site that, "There was no suction at the time of "[the]" biopsy. "[We]" had to dispose the needle and use a new one." Additional information was obtained from the user site in which it was confirmed that "A new needle package was opened and used." The user further reported that "there was a new needle insertion at the site of the biopsy." No patient/user harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841356 ↗
• MalfunctionSep 21, 2026Contamination

  It was reported by the user site that "The connecting part of the canister that holds the specimen was damaged. It had a substance that coated the outside of the canister." The issue was identified prior to the procedure and prior to patient use. The procedure was completed successfully using another device. No patient or user harm was reported, and no additional medical or surgical intervention was required.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841179 ↗
• MalfunctionSep 21, 2026Contamination

  It was reported by the user site that the "Outside of specimen cup was very sticky/greasy." Customer outreach confirmed that "It may very well have been excessive device lubricant but I cannot confirm." The issue was identified prior to patient use and the device was removed from service. No patient or user harm was reported, and no additional medical or surgical intervention was required.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840941 ↗
• MalfunctionSep 21, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840782 ↗
• InjuryJul 27, 2026Failure to Obtain Sample

  It was reported that during a breast biopsy that the customer lost the samples as there was no filter in the specimen chamber. There was no reported harm and the procedure was able to be successfully completed with another device. However, customer outreach confirmed that losing the samples resulted in the "additional samples needed to be obtained by the radiologist."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045701 ↗
• InjuryMay 5, 2026Component Missing

  THE FOLLOWING WAS REPORTED BY THE USER AFTER AN ATEC BREAST BIOPSY PROCEDURE ON (B)(6) 2026, "WE PERFORMED A 3-SITE BIOPSY ON THIS PATIENT. WHEN WE WERE DONE, WE OPENED THE CONTAINER TO PULL OUT THE BASKET WITH THE SAMPLE IN IT. THERE WAS NO BASKET IN THE DEVICE CONTAINER. AND NO SAMPLE AS WELL. THE OTHER 2 BIOPSY SITES WERE DONE SUCCESSFULLY, AND BASKETS WERE IN THOSE DEVICES." ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER SITE IN WHICH IT WAS CONFIRMED THAT THE THIRD BIOPSY SITE COULD NOT BE SUCCESSFULLY COMPLETED. FURTHER, IT WAS REPORTED THAT THE PATIENT IS NOT CURRENTLY SCHEDULED TO RETURN FOR COMPLETION OF THE BIOPSY ON THE THIRD SITE; HOWEVER, PATHOLOGY MAY POSSIBLY BE OBTAINED ON THAT SITE DURING AN UPCOMING BREAST SURGERY. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082707 ↗
• MalfunctionApr 22, 2026Material Twisted/Bent

  IT WAS REPORTED BY THE USER SITE THAT POST A BREAST BIOPSY PROCEDURE USING AN ATEC BREAST BIOPSY DEVICE, "THE COVER OVER THE TROUGH DID NOT CLOSE PROPERLY OR AUTOMATICALLY AND SEEMED TO BE ANGLED UPWARDS." ADDITIONALLY, IT WAS REPORTED THAT "THE NEEDLE WAS HARD TO REMOVE, AND THE NURSE HAD TO PUSH ON THE BASE OF THE NEEDLE IN ORDER TO GET IT TO CLOSE." NO PATIENT OR USER HARM WAS REPORTED, AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955763 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLASTIC SHEATH ON AN ATEC DEVICE GETS STUCK ON THE PATIENT'S SKIN AND TISSUE REQUIRING A LARGE INCISION. IT IS REPORTED THAT THE USER HAS STARTED PLACING THE DEVICE TO THE CORRECT DEPTH WITH THE TROCAR, REMOVING THE TROCAR, PUTTING IN THE OBTURATOR, AND PUSHING IT UNTIL IT ACTUALLY GOES THROUGH THE SKIN INSTEAD OF TENTING, AND THEN PULLING BACK. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23632973 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLASTIC SHEATH ON AN ATEC DEVICE GETS STUCK ON THE PATIENT'S SKIN AND TISSUE, REQUIRING A LARGE INCISION. IT WAS REPORTED THAT DESPITE GOOD COMPRESSION AND AN ADEQUATE INITIAL SKIN INCISION, THE INCISION NEEDED TO BE ELONGATED FOR THE DEVICE TO PENETRATE THROUGH THE SKIN. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23632909 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLASTIC SHEATH AN ATEC DEVICE GETS STUCK TO THE PATIENT'S SKIN AND TISSUE, REQUIRING A LARGER SKIN INCISION. IT IS REPORTED THAT THE END OF THE SHEATH DOES NOT SEEM SMOOTH. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23632864 ↗
• InjuryMay 15, 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, AN ARTIFACT WAS OBSERVED IN THE PATIENT'S BREAST AFTER AN MRI BIOPSY IN ADDITION TO THE TRIMARKTD-2S-13-MR MARKER THAT WAS DEPLOYED AT THE TIME. IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, THE CUSTOMER REPORTS THAT THE PATIENT REQUIRED ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22029993 ↗
• InjuryMay 15, 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, AN ARTIFACT WAS OBSERVED IN THE PATIENT'S BREAST AFTER AN MRI BIOPSY IN ADDITION TO THE SMARK-M-SS2 MARKER THAT WAS DEPLOYED AT THE TIME. IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, THE CUSTOMER REPORTS THAT THE PATIENT REQUIRED ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22029992 ↗
• InjuryDec 7, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, AN ATEC PROCEDURE WAS PERFORMED AND THE DEVICE WOULD NOT FUNCTION WHEN INSERTED INTO SITE. PROCEDURE WAS NOT COMPLETED, A MARKER WAS PLACED AND THE PROCEDURE WAS THEN COMPLETED UNDER MAMMO. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936369 ↗
• MalfunctionDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 A ATEC PROCEDURE WAS PERFORMED AND THE CONSOLE DID NOT WORK DURING THE PROCEDURE AND WHILE THE PATIENT WAS ALREADY AT THE TABLE WITH THE BREAST COMPRESSED FOR BIOPSY. IT HAD FLASHING GREEN LIGHT. THE PHYSICIAN TRIED ALL TROUBLESHOOTING TECHNIQUES LISTED ON THE CHART, AND EVEN CHANGED THE BIOPSY NEEDLE TWICE. PATIENT IS NOT YET RESCHEDULED FOR A NEW PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15911324 ↗
• MalfunctionDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 A ATEC PROCEDURE WAS PERFORMED AND THE CONSOLE DID NOT WORK DURING THE PROCEDURE AND WHILE THE PATIENT WAS ALREADY AT THE TABLE WITH THE BREAST COMPRESSED FOR BIOPSY. IT HAD FLASHING GREEN LIGHT. THE PHYSICIAN TRIED ALL TROUBLESHOOTING TECHNIQUES LISTED ON THE CHART, AND EVEN CHANGED THE BIOPSY NEEDLE TWICE. PATIENT IS NOT YET RESCHEDULED FOR A NEW PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15910265 ↗
• MalfunctionMay 5, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A BIOPSY THE USER NOTICED THE PLASTIC SHEATH WAS DIFFICULT TO REMOVE AND A PIECE OF IT HAD BROKEN OFF. NO INJURY REPORTED. THE REPORTED DEVICE WAS DISCARDED BY THE CUSTOMER. THE CUSTOMER HAS NOT REPORTED ANY SIMILAR ISSUES SINCE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778522 ↗

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