Tumark® Professional X for Eviva® Standard TUMARK-E13-S-X-02Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04250195612069), received between May 21, 2026 and May 21, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Migration1
- Use of Device Problem1
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 21, 2026Use of Device Problem; Migration
IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE ON (B)(6) 2026, USING A TUMARK BIOPSY SITE MARKER, THE "X MARKER WAS DEPLOYED, STEREO PICTURE WAS TAKEN AND MARKER WAS SEEN. HELD PRESSURE FOR 10 MINUTES AND THEN TOOK "[THE]" PATIENT TO "[THE]" MAMMO ROOM FOR POST PICTURES. MARKER WAS NOT SEEN ON CC OR MLO PICTURES." ADDITIONAL INFORMATION WAS OBTAINED FROM THE CUSTOMER IN WHICH THE CUSTOMER DENIES THE OBSERVATION OF HEAVY BLEEDING WHEREAS THE MARKER MAY HAVE BEEN INADVERTENTLY FLUSHED OUT AND REPORTS THAT HOLDING PRESSURE AT THE SITE FOR 10 MINUTES "IS OUR AVERAGE PRESSURE TIME." IT IS REPORTED THAT THE CANNULA, 4X4 GAUZE AND SURROUNDING AREAS WERE SEARCHED FOR THE MARKER; HOWEVER, IT COULD NOT BE LOCATED. NO PATIENT HARM OR ADDITIONAL INTERVENTIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25242335 ↗
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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