ATEC Introducer ILS 0914-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05420045503208), received between Jul 10, 2018 and Sep 22, 2026 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  It was reported by the user site that a part of the needle guide "popped off." It is reported that the procedure was successfully completed with another device. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854157 ↗
• InjuryJul 27, 2026Break

  The customer reported the MRI introducer valve, also known as silicone elastomer or silicone valve, pushed into the introducer as the needle advanced into the introducer. The silicone elastomer remained in the patient¿s breast which was confirmed by a post-procedural mammogram. This resulted in the patient requiring surgery to remove the silicone elastomer. No further information is available at this time.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50010953 ↗
• InjuryNov 18, 2025Material Fragmentation; Material Fragmentation

  IT IS REPORTED BY THE USER SITE THAT DURING AN ATEC MRI BIOPSY PROCEDURE ON (B)(6) 2025, FOREIGN MATERIAL WAS LEFT IN THE PATIENT'S BREAST. IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE; HOWEVER, 13 DAYS POST PROCEDURE, THE PATIENT REPORTED OBSERVING A "WHITE CIRCULAR PIECE OF PLASTIC" PROTRUDING FROM THE BIOPSY SITE. IT WAS FURTHER REPORTED THAT THE PATIENT AGAIN RETURNED 24 DAYS POST PROCEDURE WITH A SIMILAR OBSERVATION OF FOREIGN MATERIAL PROTRUDING FROM THE BIOPSY SITE. THE USER SITE REPORTS THAT THE RADIOLOGIST WAS ABLE TO PULL THE FOREIGN MATERIAL OUT OF THE BIOPSY SITE ON BOTH OCCASIONS AND THAT THE PATIENT IS PHYSICALLY "OKAY." IT IS REPORTED BY THE USER SITE THAT REVIEW OF THE POST PROCEDURE IMAGES INDICATES A CIRCULAR PIECE OF FOREIGN MATERIAL WAS OBSERVED JUST BENEATH THE SKIN. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23586248 ↗
• InjuryJun 30, 2025Material Fragmentation; Adverse Event Without Identified Device or Use Problem; Material Fragmentation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON APRIL 10TH, 2025, AN ARTIFACT WAS OBSERVED IN THE PATIENT´S BREAST AFTER AN MRI BIOPSY IN ADDITION TO THE MARKER (TRIMARK MARKER) THAT WAS DEPLOYED AT THE TIME. THE PATIENT RECEIVED ANOTHER MAMMOGRAM ON APRIL 10TH, 2025, DUE TO THE ARTIFACT AND THE RADIOLOGIST RECOMMENDED THAT THE PATIENT HAVE SURGERY TO HAVE THE MATERIAL REMOVED, WHICH WAS SCHEDULED FOR (B)(6) 2025. NO ISSUES WERE REPORTED DURING THE DEVICE SET UP. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 22365480 ↗
• InjuryJun 30, 2025Material Fragmentation; Adverse Event Without Identified Device or Use Problem; Material Fragmentation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) 2025, AN ARTIFACT WAS OBSERVED IN THE PATIENT'S BREAST AFTER AN MRI BIOPSY IN ADDITION TO THE TRIMARKTD-2S-13-MR MARKER THAT WAS DEPLOYED AT THE TIME. IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, THE CUSTOMER REPORTS THAT THE PATIENT REQUIRED ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22365348 ↗
• InjuryJun 30, 2025Material Fragmentation; Adverse Event Without Identified Device or Use Problem; Material Fragmentation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE ON (B)(6) 2025, AN ARTIFACT WAS OBSERVED IN THE PATIENT'S BREAST AFTER AN MRI BIOPSY IN ADDITION TO THE SMARK-M-SS2 MARKER THAT WAS DEPLOYED AT THE TIME. IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, THE CUSTOMER REPORTS THAT THE PATIENT REQUIRED ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22365222 ↗
• InjuryJun 25, 2025Material Fragmentation; Adverse Event Without Identified Device or Use Problem; Material Fragmentation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025, THAT A SECURMARK MRI IMPLANTABLE BREAST MARKER WAS PLACED IN A PATIENT DURING AN MRI BIOPSY USING AN ATEC DEVICE. IT IS REPORTED THAT DURING THE POST PLACEMENT MAMMOGRAM, A RING/CIRCLE WAS OBSERVED IN THE IMAGE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 22330686 ↗
• InjuryApr 24, 2025Material Fragmentation; Adverse Event Without Identified Device or Use Problem; Material Fragmentation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ATEC PROCEDURE IN (B)(6) 2025, WHILE USING THE ATEC INTRODUCER LOCALIZATION SET FOR MRI AND MRI BREAST BIOPSY. THE TROCAR WAS DIFFICULT TO PLACE THROUGH THE INTRODUCER AND MET SOME INITIAL RESISTANCE BUT SUBSEQUENTLY WAS ABLE TO SLIDE THROUGH EASILY ON REPEAT. CHECK PERFORMED PRIOR TO PLACEMENT IN PATIENT. FOLLOWING THE UNEVENTFUL BIOPSY, POST BIOPSY MAMMOGRAM SHOWED A SMALL HIGH-DENSITY RING ADJACENT TO THE BIOPSY MARKER WHICH WAS NOT IN PATIENT´S BREAST ON PRE PROCEDURE MAMMOGRAM. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21901211 ↗
• InjuryJun 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) A BIOPSY PROCEDURE WAS PERFORMED AND DURING THE PROCEDURE THE THE BROWN CAP CAME OFF THE DEVICE AND THE PATIENT NEEDED TO BE RESAMPLED AND ANOTHER DEVICE USED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19504960 ↗
• InjuryJan 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN MRI BIOPSY ON DECEMBER 13TH, 2023, DURING THE BIOPSY THE INTRODUCER LOCALIZATION TROCAR SYSTEM CAP DETACHED INSIDE THE PATIENT, THE DEFECTIVE EQUIPMENT WAS REMOVED, AND A SECOND LOCALIZATION SYSTEM WAS OPENED. THE SAME ISSUE HAPPENED AGAIN BUT THE RADIOLOGIST HELD THE PIECE IN PLACE AND CONTINUED WITH THE BIOPSY. UNKNOWN TO THE RADIOLOGIST THAT A MALLEABLE PIECE HAD BEEN LODGED INTO THE TROCAR CASING WHEN THE RADIOLOGIST ADVANCED THE TROCAR INTO THE PATIENT IT LODGED THE MALLEABLE DEFECTIVE PIECE INTO THE PATIENT'S LEFT BREAST. IT WAS DISCOVERED WHEN THE PATIENT WENT FOR A POST-MAMMOGRAM CLIP PLACEMENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18542251 ↗
• InjuryJan 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN MRI BIOPSY ON (B)(6) 2023, DURING THE BIOPSY THE INTRODUCER LOCALIZATION TROCAR SYSTEM CAP DETACHED INSIDE THE PATIENT, THE DEFECTIVE EQUIPMENT WAS REMOVED, AND A SECOND LOCALIZATION SYSTEM WAS OPENED. THE SAME ISSUE HAPPENED AGAIN BUT THE RADIOLOGIST HELD THE PIECE IN PLACE AND CONTINUED WITH THE BIOPSY. UNKNOWN TO THE RADIOLOGIST THAT A MALLEABLE PIECE HAD BEEN LODGED INTO THE TROCAR CASING WHEN THE RADIOLOGIST ADVANCED THE TROCAR INTO THE PATIENT IT LODGED THE MALLEABLE DEFECTIVE PIECE INTO THE PATIENT'S LEFT BREAST. IT WAS DISCOVERED WHEN THE PATIENT WENT FOR A POST-MAMMOGRAM CLIP PLACEMENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18542248 ↗
• InjuryJul 25, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED A PHYSICIAN PERFORMED AN ATEC BREAST BIOPSY PROCEDURE ON (B)(6) 2018 AND WHEN THE PHYSICIAN WAS WITHDRAWING THE NEEDLE FROM THE INTRODUCER THERE WAS RESISTANCE THAT CAUSED THE NEEDLE TO "DEFLECT UP" WHEN REMOVING AND CAUSED THE PHYSICIAN TO RECEIVE A NEEDLE STICK. IT IS UNKNOWN IF INTERVENTION WAS REQUIRED. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 7719898 ↗
• MalfunctionJul 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A PHYSICIAN PERFORMED A BREAST BIOPSY PROCEDURE ON (B)(6) 2018 AND THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2018, THE PATIENT RETURNED FOR HER MARKER PLACEMENT. ON (B)(6) 2018, DURING THE EXCISION PROCEDURE THE TECHNICIAN NOTICED A PLASTIC PIECE. THE PIECE WAS REMOVED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673548 ↗

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