ATEC 0912-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15420045504851), received between Jan 24, 2025 and Dec 10, 2025 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2025Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) 2025, "THE SETUP, TEST AND LAVAGE MODE PASSED, BUT ALTHOUGH THE APERTURE WAS OPENING AND CLOSING, NO TISSUE WAS BEING COLLECTED." ADDITIONALLY, IT WAS REPORTED THAT, "THESE NEW NEEDLES ARE DELIVERED WITH AN EXCESSIVE AMOUNT OF GREASE ON THE HANDPIECE AREA, PARTICULARLY AROUND THE BASKET-TO-HANDPIECE CONNECTION. THIS DOES AFFECT THE SUCTION PERFORMANCE, ESPECIALLY WITH LARGER LESIONS OR WHEN A COMPLETE EXCISION IS INTENDED." IT IS REPORTED THAT THE PATIENT PROCEDURE WAS ABORTED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770489 ↗
• MalfunctionJan 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON (B)(6) 2024 A PHYSICIAN REPORTED THAT SOMETIMES WHEN PERFORMING A BIOPSY WITH AN ATEC NEEDLE THEY NOTICED A PIECE OF MATERIAL PLASTIC IN BETWEEN THE SPECIMENS. PHYSICIAN PROVIDED A PICTURE IN WHICH IT CAN BE OBSERVED A PLASTIC PARTICLE MIXED ALONG WITH THE SAMPLES. THE PARTICLES WERE ONLY OBSERVED IN THE SAMPLES AND NOT IN THE PATIENTS. NO SAMPLES HAVE BEEN OBSERVED IN THE BREAST OF THE PATIENT. PHYSICIAN REPORTED THAT NO INJURY WAS REPORTED TO PATIENTS NOR USERS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233057 ↗

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