ATEC Introducer ILS 0914-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05420045503192), received between Dec 21, 2017 and Sep 17, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Material Separation

  It was reported by the user site that upon the Radiologist removing the device from the packaging, "a small valve inside is separating from the rest of the guide." It is reported that the Radiologist opened another package and was able to complete the biopsy procedure. No patient or user harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805533 ↗
• MalfunctionApr 13, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BROWN TOP OF THE INTRODUCER SHEATH IS NOT PROPERLY CONNECTED/SECURE AND WILL FALL OFF WHILE ATTEMPTING TO GAIN ACCESS TO THE BREAST TO PERFORM THE BIOPSY. A RADIOLOGIST WAS STUCK WITH A NEEDLE WHEN THE BROWN TOP DETACHED FROM THE REST OF THE SHEATH. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11660921 ↗
• MalfunctionJun 14, 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 TIP OF THE PLASTIC INTRODUCER REMAINED INSIDE THE PATIENT. THE PHYSICIAN REMOVED THE PIECE AND COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE PATIENT WAS DISCHARGED HOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7602845 ↗
• MalfunctionDec 21, 2017Break; Break

  IT WAS REPORTED A PHYSICIAN PERFORMED A BREAST BIOPSY PROCEDURE ON (B)(6) 2017 AND "DURING THE PROCEDURE THE COLORED RING FROM THE INTRODUCER SHEET AT THE BACK SIDE BROKE OFF. THIS CREATED AN OPEN CONNECTION WITH THE BREAST TISSUE." THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS COMPLETED WITH A SECOND DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7137537 ↗

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