ATEC 0914-12MRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045504875), received between Jul 8, 2025 and Jul 8, 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 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.

• InjuryJul 8, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT IS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6), 2025, THE USER OBSERVED A CLEAR, GREASY SUBSTANCE ON THE SPECIMEN COLLECTION BASKET. IT IS REPORTED THAT THIS SUBSTANCE INTERFERED WITH THE ABILITY OF THE DEVICE TO PROPERLY SEAL, RESULTING IN AIR LEAKAGE. AS A RESULT, IT IS REPORTED THAT THE PROCEDURE WAS ABORTED AFTER THE INITIAL INCISION HAD BEEN MADE AND THE PATIENT HAD TO RETURN ON ANOTHER DAY FOR ANOTHER BIOPSY, REQUIRING A SECOND INCISION SITE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22441254 ↗

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