ATEC EMERALDRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045506848), received between Dec 30, 2025 and Dec 30, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Obtain Sample” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED BY THE USER SITE THAT DURING AN ATEC EMERALD PROCEDURE ON (B)(6) 2025, THE "RETEST HANDPIECE LIGHT CAME ON DURING PROCEDURE AFTER SEVERAL SAMPLES ACQUIRED, SYSTEM LOST SUCTION. SITE SWITCHED OUT HANDPIECE, TRIED PETITE HANDPIECE AS WELL, UNABLE TO COMPLETE SETUP. PROCEDURE COMPLETED WITH EXISTING SAMPLES." ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER SITE, INDICATING "THE PATIENT WAS ACCESSED FOR 2 SEPARATE BIOPSIES OF THE SAME BREAST, AND THE MACHINE QUIT WORKING WHEN TAKING SAMPLES OF THE FIRST ACCESS. THE RADIOLOGIST WAS ABLE TO COLLECT HALF OF THE SAMPLES ON THE FIRST ACCESS FOR THIS PATIENT." NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926993 ↗

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