SecurMark for ATEC SMARK-ATEC-13-12Recalls & reported problems
Hologic, Inc. · SecurMark for Atec · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05420045503437), received between May 18, 2026 and May 18, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2026Migration
IT WAS REPORTED BY THE USER THAT DURING THEIR SECOND BREAST BIOPSY CASE ON (B)(6) 2026, USING A SECURMARK FOR ATEC DISPOSABLE DEVICE, MARKER MIGRATION WAS OBSERVED. THE USER REPORTS THAT "IT APPEARS THAT THE MARKER MIGRATION OCCURRED AFTER THE MARKER HAD BEEN PLACED IN THE FINAL INTENDED POSITION." THE USER FURTHER REPORTS THAT THE MARKER "APPEARED TO BE IN THE CORRECT LOCATION DIRECTLY AFTER THE POST MARKER PLACEMENT IMAGE WAS TAKEN ON THE STEREOTACTIC UNIT BUT SHOWED A 4 CM LATERAL MIGRATION ON THE POST PROCEDURE IMAGES." IT IS REPORTED THAT THERE WAS NO PATIENT HARM; HOWEVER, THE MARKER PLACEMENT PROCESS WAS ABORTED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25209101 ↗
Other MARKER, RADIOGRAPHIC, IMPLANTABLE devices
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- BioZorb F0221Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE3 recalls15 reports
- BioZorb F0203Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls51 reports
- BioZorb F0231Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0303Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0304Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0404Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls6 reports
- BioZorb F0331Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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