TUMARK Professional 271560Recalls & reported problems
SOMATEX Medical Technologies GmbH · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 04250195600813), received between Feb 14, 2023 and Feb 14, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 18, 2026.
Most reported problems
Device problems
- Patient-Device Incompatibility1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 14, 2023Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2023, A PATIENT RECEIVED AFTER A BREAST BIOPSY A TUMARK MARKER U SHAPED AND 2 ADDITIONAL MARKERS FROM A DIFFERENT COMPANY (2 THIRD PARTY COMPANY CLIPMARKERS). ADDITIONALLY, 2 DEVICES FROM THIRD PARTY COMPANIES (NEEDLES) AND BANDAGES WERE USED ON THE PATIENT AS WELL AS LOCAL DOSE OF ANESTHETICS. AFTER THE PROCEDURE THE PATIENT DEVELOPED A GIANT URTICARIAL REACTION TO THE CHEST, ARM GROINS AND NECK FOR WHICH SHE RETURNED TO THE EMERGENCY ROOM. DUE TO THE PATIENT PERSISTING WITH AN ALLERGIC REACTION, ALL THE MARKERS WERE REMOVED 3 DAYS AFTER IMPLANTATION, THE PATIENT RECEIVED A HIGH DOSE OF ANTIHISTAMINES AND CORTICOSTEROIDS. A FEW DAYS AFTER THE REMOVAL AND DUE TO THE TREATMENT, THE PATIENT WAS DOING MUCH BETTER. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 16371889 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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