SecurMark MRI SMARK-M-SS2Recalls & reported problems
Hologic, Inc. · SecurMark MRI Biopsy site marker · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05420045503987), received between Nov 30, 2018 and May 15, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Eject” (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
- Adverse Event Without Identified Device or Use Problem1
- Failure to Eject1
Patient problems
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A SMARK-M-SS2 FOR ATEC PROCEDURE ON (B)(6) 2025, AN ARTIFACT WAS OBSERVED IN THE PATIENT'S BREAST AFTER AN MRI BIOPSY. 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 22031098 ↗MalfunctionNov 30, 2018Failure to Eject; Failure to Eject
IT WAS REPORTED THAT "DURING MRI BIOPSY OF BREAST, CLIP DID NOT DEPLOY PROPERLY AT END OF PROCEDURE. PATIENT HAD TO HAVE ANOTHER PROCEDURE WITH ULTRASOUND GUIDANCE TO PLACE THE CLIP." NO INJURY OR MISDIAGNOSIS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8121738 ↗
Other MARKER, RADIOGRAPHIC, IMPLANTABLE devices
- BioZorb F0202Hologic, Inc. · MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls192 reports
- 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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