ATEC 1212-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 15420045504912), received between May 21, 2025 and Sep 30, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Failure to Obtain Sample

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946556 ↗
• MalfunctionSep 24, 2026Insufficient Device Problem Information

  It was reported by the user site that the device "malfunctioned during the breast biopsy procedure." No additional information regarding the nature of the malfunction, patient or user impact, or procedure outcome was provided. Multiple outreach attempts were made to the appropriate regional contact; however, no additional information was obtained. If additional information is later received, the reportability decision will be reevaluated. This report was forwarded by the Brazilian Competent Authority (ANVISA) under reference number 2026.08.004729.

  Patient problems: Insufficient Information

  MAUDE report 50882354 ↗
• InjurySep 21, 2026Suction Problem

  It was reported by the user site that during a mammotomy procedure, "the biopsy needle had to be replaced because it lost vacuum during the procedure." As a result of the reported malfunction, tissue could not be adequately acquired from the target area with the initial device. No patient or user harm was reported.

  Patient problems: Insufficient Information

  MAUDE report 50839941 ↗
• MalfunctionSep 21, 2026Failure to Cycle

  It was reported by the user site that during setup and testing of the device, "Needle would not open and close during testing." Customer outreach confirmed that "The needle opened at first and got stuck during the test trying to close again." The issue was identified during device testing prior to patient use. 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 50839176 ↗
• InjurySep 15, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ATEC BIOPSY PROCEDURE ON (B)(6) 2025, SALINE FLOW AND SAMPLING ISSUES WERE EXPERIENCED. THE USER REPORTS THAT THE DEVICE PRE-PROCEDURE SET-UP AND TESTING WERE OKAY BUT MORE SALINE THAN USUAL WAS OBSERVED DRIPPING OUT OF THE END OF THE NEEDLE WHEN IT WAS LIFTED TO BE INSERTED INTO THE PATIENT'S BREAST. THE USER FURTHER REPORTS THAT SIX CORES WERE COMPLETED AND X-RAYED BUT NO CALCIFICATION WAS OBSERVED. THE USER REPORTS THAT ANOTHER SIX CORES WERE OBTAINED WITH NO CALCIFICATION OBSERVED AND AGAIN ANOTHER SIX CORES, STILL WITH NO CALCIFICATION. THE USER REPORTS THAT AFTER EIGHTEEN CORES, THE PATIENT WAS BLEEDING AND THE USER SITE OBSERVED THAT THE SALINE BAG WAS ALL EMPTIED INTO THE WASTE BOTTLE. IT IS REPORTED THAT THE BIOPSY WAS UNSUCCESSFUL, THE PATIENT EXPERIENCED A HEMATOMA AND HAD TO BE RESCHEDULED FOR ANOTHER BIOPSY PROCEDURE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Hematoma

  MAUDE report 23057240 ↗
• InjurySep 4, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) 2025, THE USER TESTED THE NEEDLE, COMPLETED THE BIOPSY AND OBSERVED THE TISSUE SAMPLES IN THE FILTER WHILE PERFORMING THE LAVAGE; HOWEVER, THE USER REPORTS THAT UPON ATTEMPTING TO OBTAIN THE TISSUE FROM THE FILTER, IT WAS NOT PRESENT. THE USER REPORTS THAT A SECOND PROCEDURE WAS REQUIRED TO OBTAIN ADDITIONAL TISSUE SAMPLES AS THE INITIAL TISSUE SAMPLES WERE NEVER FOUND. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22966635 ↗
• InjuryMay 21, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING AN ATEC PROCEDURE, THE ATEC NEEDLE WAS NOT SUCTIONING. THE CUSTOMER REPORTS THAT NO SAMPLES WERE PULLED INTO THE TISSUE FILTER AND ONE SMALL SAMPLE WAS IN THE APERTURE. AS A RESULT, THE PROCEDURE COULD NOT BE COMPLETED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061366 ↗

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