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SecurMark SMARK-CELERORecalls & reported problems

Hologic, Inc. · SecurMark for Celero · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05420045503390), received between Oct 19, 2022 and Oct 19, 2022 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, WHILE USING MULTIPLE MARKERS FOR PLACEMENT. AFTER PLACING A PATH BARREL CLOSE TO THE SKIN THE TECHNICIAN TOOK POSTFIRE PICTURES AND REALIZED THAT AN OBLONG PLASTIC LOOKING PIECE WAS INSIDE THE PATIENT´S BREAST. THIS WAS NOT PRESENT PRE-FIRE AND ONLY HOLOGIC MARKERS WERE USED. THE RADIOLOGIST ATTEMPTED TO RETRIEVE IT BUT FAILED TO GET IT OUT. THE PATIENT HAS BREAST CANCER AND WILL UNDERGO SURGERY IN WHICH THEY WILL TAKE THE PLASTIC AS WELL.

    Patient problems: Foreign Body In Patient

    MAUDE report 15632852 ↗

Other MARKER, RADIOGRAPHIC, IMPLANTABLE devices

All MARKER, RADIOGRAPHIC, IMPLANTABLE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.