Gel Mark UltraCor® Breast Tissue Marker GMUTC005TRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741031908), received between Apr 6, 2016 and Aug 13, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A MAMMOGRAPHY GUIDE BREAST TISSUE MARKER PLACEMENT PROCEDURE USING THE GELMARK ULTRACOR. IT WAS NOTICED THAT, POST THE PROCEDURE ON MAMMO IMAGES, THE CLIP WAS NOT S SHAPED BUT LINEAR IN SHAPE ON SEVERAL DIFFERENT MAMMO IMAGES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792085 ↗
• MalfunctionMar 12, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A PATIENT UNDERWENT FOR A BREAST TISSUE MARKER PLACEMENT PROCEDURE USING GELMARK ULTRACOR MARK. DURING THE PROCEDURE THE PIECE OF PLASTIC COMES OFF WHEN DEPLOYING THE MARKER IN THE BREAST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21582333 ↗
• MalfunctionMar 15, 2017Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT POST BREAST TISSUE MARKER PLACEMENT, THE MARKER ALLEGEDLY COULD NOT BE SEEN UNDER ULTRASOUND AND MAMMOGRAM. IT IS UNKNOWN IF ANOTHER MARKER WAS PLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6406020 ↗
• MalfunctionApr 6, 2016Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT POST BREAST TISSUE MARKER PLACEMENT IN THE RIGHT AXILLARY LYMPH NODE AND BREAST, THE PATIENT ALLEGED FEVER, PAIN, INFECTION AND A LUMP AROUND THE BIOPSY SITE. THE PATIENT DID NOT REPORT OF MEDICAL TREATMENT PROVIDED FOR THE REPORTED SYMPTOMS. THE PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Pain; Reaction; Unspecified Infection

  MAUDE report 5553071 ↗