SecurMark SMARK-CELERO-2SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05420045503406), received between Nov 25, 2019 and Nov 15, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 78-YEAR-OLD PATIENT ON AN UNKNOWN DATE IN 2021, A PATIENT RECEIVED A SMARK-CELERO 2S MARKER DURING A BREAST BIOPSY RELATED TO DCIS. PATIENT REPORTED THAT AFTER THE SURGERY SHE STARTED HAVING REPEATED COUGH EPISODES, SNEEZING WITH RUNNING NOSE, AND ATRIAL FIBRILLATION EPISODES AND HER HYPERTENSION GOT WORSE. PATIENT REPORTED THAT SHE SUFFERED PNEUMONIA AND X-RAY AND CT-SCAN SHOWED ABNORMALITIES AND CHANGES IN HER THYROID. PATIENT REPORTED THAT HER ECZEMA FLARED SO BAD THAT SHE STARTED TO EXPERIENCE DEPIGMENTATION OF HER SKIN ALL OVER HER BODY. PATIENT REPORTED THAT SHE EXPERIENCED AN ALLERGIC REACTION TO THE MARKER AND THAT THE MARKER HAD BEEN MISPLACED AND NOT IN THE LESION RELATED TO THE DCIS. PATIENT REPORTED A HISTORY OF MULTIPLE ALLERGIES TO MRI CONTRAST, HAIR COLOR, JEWELRY, AND A HISTORY OF DELAYED HYPERSENSITIVITY REACTION TO ALLERGENS. PATIENT REPORTS THAT SHE IS LOOKING FOR A PHYSICIAN TO REMOVE THE MARKER DUE TO THE SYSTEMIC REACTION. NO OTHER INFORMATION AVAILABLE. MEDICATION RECEIVED: AMLODIPINE, B12, BENADRYL, CORTIZOL SKIN OINTMENT, FLECAINIDE, LETROZOLEIT, NEBIVOLOL. ETHNICITY: NON-HISPANIC AND ASIAN.

  Patient problems: Atrial Fibrillation; Cough; Erythema; Hyperpigmentation; Hypersensitivity/Allergic reaction; Hypopigmentation; Itching Sensation; Pulmonary Hypertension; Rash; Sleep Dysfunction

  MAUDE report 20699186 ↗
• MalfunctionNov 25, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DOUBLE BREAST BIOPSY FOR TWO DIFFERENT BREAST MASSES. MARKERS WERE PLACED SUCCESSFULLY. UPON COMPLETION OF THE POST BIOPSY MAMMOGRAM TO ENSURE THE CORRECT PLACEMENT OF THE MARKERS, IT WAS NOTED THAT ONE MARKER WAS ACTUALLY AN X SHAPED MARKER AND NOT A TOP HAT MARKER THAT THE PACKAGING STATED. THE PATIENT WAS NOT INJURED OR MISDIAGNOSED AS A RESULT OF THIS. ADDITIONAL INFORMATION FROM THE FACILITY STATES "IT MIGHT HAVE BEEN AN ISSUE WITH MULTIPLE MARKERS IN PATIENT AND NOTHING IS WRONG WITH HOLOGIC DEVICES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9373172 ↗