ATEC 0909-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15420045504844), received between Jul 24, 2018 and Jan 6, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Decrease in Suction” (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.

• InjuryJan 6, 2020Device Slipped; Device Slipped

  IT WAS REPORTED THAT WHEN THE PROTECTIVE COVER WAS RECAPPED, "THE PLASTIC PART AT THE TIP FLEW FORWARD AND BLOOD ENTERED THE EYES." THE "EXAMINEE WAS CONFIRMED NOT INFECTED." NO ADDITIONAL DETAILS AVAILABLE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 9556074 ↗
• MalfunctionJul 24, 2018Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THE PHYSICIAN PERFORMED AN ATEC BREAST BIOPSY PROCEDURE ON (B)(6) 2018, AND THE "SPECIMEN GET SUCKED INTO THE NEEDLE, NO ASPIRATION OF THESE SPECIMENS AND NO POSSIBILITY TO HAVE THEM COLLECTED INTO THE CHAMBER. WHEN INSERTING THE MARKER INTO THE ATEC BIOPSY DEVICE IT PUSHED SPECIMENS BACK INTO THE BREAST". THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SECOND DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7715673 ↗

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