ATEC ATEC CanisterRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045503182), received between Nov 20, 2024 and Nov 20, 2024 — 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 16, 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.

• InjuryNov 20, 2024Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT ON A BREVERA PROCEDURE WITH AN ATEC CANNISTER ON (B)(6) 2024, THE TECH REPORTED THAT THE SYSTEM DISPLAYED AN ERROR RELATED TO VACUUM SYSTEM NOT AT REQUIRED PRESSURE WHEN THE NEEDLE WAS INSERTED INTO THE PATIENT´S BREAST AND FIRED. NO SAMPLES COULD BE OBTAINED, AND THE SYSTEM WAS UNABLE TO BE RECONNECTED AND THE PATIENT WAS RESCHEDULED FOR A NEW PROCEDURE. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND IT WAS DETERMINED THAT THE CANISTER WAS NOT SEALING CORRECTLY AS EXPECTED WHICH CAUSED THE VACUUM ERROR ON THE SYSTEM. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20740054 ↗

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