ATEC Sapphire 200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15420045504110), received between Apr 28, 2023 and Oct 20, 2023 — classified as 2 injuries.

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

• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING AN ATEC PROCEDURE, THE NEEDLE FAILED WHILE INSIDE THE BREAST. THE PATIENT HAD TO BE RESCHEDULED FOR A NEW PROCEDURE. THE CONSOLE WAS EXAMINED BY A FIELD ENGINEER AND IT WAS DETERMINER NO DEVICE ISSUES FOUND. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981129 ↗
• InjuryApr 28, 2023Suction Failure; Suction Failure

  IT WAS REPORTED THAT ON (B)(6) 2023, AN EVIVA PROCEDURE WAS GOING TO BE PERFORMED, AND WHEN THE NEEDLE WAS ASSEMBLED ON THE ATEC SAPPHIRE, THE UNIT FAILED THE SETUP TEST. IT WAS TROUBLESHOT DUE TO THE CANISTER NOT BEING COMPLETELY CLOSED TO ALLOW FOR THE VACUUM. THE ATEC SAPPHIRE WAS RETESTED AND PASSED ALL TESTS. THE EVIVA WAS INSERTED INTO THE BREAST FOR BIOPSY, AND THE ATEC SAPPHIRE FAILED TO COLLECT THE SAMPLE AND ERROR CODED ("VACUUM READY" SOLID RED). THE NEEDLE WAS REMOVED FROM THE BREAST AND RETESTING WAS ATTEMPTED BUT FAILED. THE PROCEDURE WAS ABORTED AND THE PATIENT RESCHEDULED FOR A NEW PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16832499 ↗

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