ATEC SAPPHIRE25Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15420045504288), received between Nov 30, 2018 and May 12, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Failure to Obtain Sample

  IT WAS REPORTED BY THE USER THAT PRE PROCEDURE SET UP TESTING WAS SUCCESSFULLY COMPLETED ON AN ATEC SAPPHIRE25 BREAST BIOPSY SYSTEM ON (B)(6) 2026. HOWEVER, THE USER REPORTS THAT ONCE THE PROCEDURE WAS STARTED, THEY WERE ONLY ABLE TO OBTAIN TWO SAMPLES BEFORE THE "RETEST" INDICATOR LIGHT ON THE ATEC CONSOLE CAME ON. IT IS REPORTED THAT THE USER SITE REMOVED THE NEEDLE FROM THE PATIENT; HOWEVER, THE INITIAL SAMPLES WERE INADEQUATE, AND A REPEAT PROCEDURE HAS BEEN SCHEDULED. INJURY MDR SUBMITTED DUE TO THE NEED FOR A REPEAT PROCEDURE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148137 ↗
• MalfunctionJun 8, 2023Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED ON MAY 16TH THAT DURING AN ATEC PROCEDURE WHILE THE NEEDLE WAS INSIDE THE BREAST THE NEEDLE STOPPED AND ONLY GOT HALF OF THE SAMPLE THEY WANTED. THE PATIENT WAS NOT HARMED BUT THE PROCEDURE COULD NOT BE COMPLETED AND MIGHT REQUIRE ANOTHER. THE CUSTOMER TESTED THE EQUIPMENT WITH ANOTHER NEEDLE WHICH DID NOT PASS THE TESTING PHASE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17085976 ↗
• InjuryApr 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE USING AN ATEC UNIT, "THE PATIENT BLED PROFUSELY AND WHEN THE CANISTER BECAME FULL IT RESULTED IN BACK FLOW INTO THE EQUIPMENT TUBE RENDERING IT UNUSABLE". A FIELD ENGINEER WAS DISPATCHED TO THE SITE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8565697 ↗
• MalfunctionApr 5, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE "UNIT STARTS PROCEDURE WITHOUT CUSTOMER ENGAGING THE FOOTSWITCH." NO INJURY REPORTED. THE ISSUE WAS IDENTIFIED PRIOR TO STARTING A PATIENT BIOPSY AND THE BIOPSY WAS SUCCESSFULLY COMPLETED USING ANOTHER UNIT. IT WAS DETERMINED THAT THE FOOTSWITCH NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8487961 ↗
• InjuryNov 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE USING AN ATEC UNIT, "THE PATIENT BLED PROFUSELY AND THE BLOOD LOSS FILLED THE CANISTER AND TRAVELED BACK UP THE TUBING." IT WAS REPORTED THAT, "THE PATIENT HAD A HEMATOMA AND BLED WHILE THEY WERE DOING THE BIOPSY, WHICH IN TURN FILLED THE ATEC SUROS CANISTER AND TUBING WITH BLOOD." ADDITIONAL INFORMATION INDICATED THAT THE PROCEDURE WAS ABANDONED AND HAS BEEN RESCHEDULED DEPENDING ON THE HISTOLOGY RESULT. THE HEMATOMA WAS MANAGED BY THE NURSING TEAM ACCORDING TO THEIR DIRECTIVES "(I.E. PRESSURE DRESSING AND ICE PACK ETC.). A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND REPLACED THE FILTER AND THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: Hematoma

  MAUDE report 8121742 ↗

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