Tumark Vision 271590Recalls & reported problems
SOMATEX Medical Technologies GmbH · Class 2 · Implant
Data updated Oct 18, 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 04250195607836), received between Nov 27, 2019 and Jan 9, 2026 — classified as 1 injury, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility1
- Use of Device Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2026Use of Device Problem
IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE ON (B)(6) 2025, THE USER PLACED A TUMARK VISION BREAST MARKER INTO THE BREAST OF A PATIENT "WITHOUT PROBLEMS." IT IS FURTHER REPORTED THAT THE USER LATER NEEDED TO ACQUIRE EXTRA BIOPSIES FROM THE SAME AREA AND IT APPEARS THAT THE BIOPSY NEEDLE BROKE THE PREVIOUSLY PLACED TUMARK VISION MARKER. THE USER REPORTS THAT NO FURTHER BIOPSY PROCEDURES ARE REQUIRED FOR THIS PATIENT AND THE TUMARK VISION MARKER CAN REMAIN IN THE PATIENTS BREAST. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24019746 ↗InjuryNov 27, 2019Patient-Device Incompatibility
SUSPICION OF ALLERGIC REACTION TO NICKEL RESULTING IN AN ABSCESS. APPLICATION OF THE PRODUCT AGAINST THE SPECIFIED CONTRAINDICATION (MARKER CONSISTS PARTIALLY OF NICKEL).
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 9380836 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page