Gel Mark UltraCor® Breast Tissue Marker GMUTC005SSRecalls & reported problems
Senorx, Inc. · GEL MARK ULTRACOR Breast Tissue Marker, 14 Gauge, SS "Omega" · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741031892), received between Oct 24, 2025 and Oct 24, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 reports).
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
- Break4
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2025Break; Break
A PATIENT UNDERWENT A BREAST TISSUE MARKER PLACEMENT PROCEDURE USING THE GEL MARK ULTRACOR. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE ALLEGEDLY BROKE OFF IN PIECES. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23377098 ↗MalfunctionOct 24, 2025Break; Break
A PATIENT UNDERWENT A BREAST TISSUE MARKER PLACEMENT PROCEDURE USING THE GEL MARK ULTRACOR. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE ALLEGEDLY BROKE OFF IN PIECES. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23377097 ↗MalfunctionOct 24, 2025Break; Break
A PATIENT UNDERWENT A BREAST TISSUE MARKER PLACEMENT PROCEDURE USING THE GEL MARK ULTRACOR. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE ALLEGEDLY BROKE OFF IN PIECES. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23377096 ↗MalfunctionOct 24, 2025Break; Positioning Failure; Break; Positioning Failure
A PATIENT UNDERWENT A BREAST TISSUE MARKER PLACEMENT PROCEDURE USING THE GEL MARK ULTRACOR. DURING THE PROCEDURE, IT WAS REPORTED THAT THE MARKER WAS ALLEGEDLY NOT DEPLOYED. FURTHER, IT WAS REPORTED THAT THE NEEDLE BROKE OFF IN PIECES. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23377095 ↗
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