UltraCor® Breast Tissue Marker UCTC17GSSRecalls & reported problems
Senorx, Inc. · ULTRACOR® Breast Tissue Marker, SS "Coil" · 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 00801741032202), received between Apr 17, 2019 and Apr 3, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Signal Artifact/Noise” (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
- Adverse Event Without Identified Device or Use Problem1
- Signal Artifact/Noise1
Patient problems
- Hypersensitivity/Allergic reaction1
- No Consequences Or Impact To Patient1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT SOMETIME POST A BREAST MARKER PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED ALLERGIC REACTION, PAIN AND IRRITATION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Hypersensitivity/Allergic reaction; Pain
MAUDE report 21759592 ↗MalfunctionApr 17, 2019Signal Artifact/Noise; Signal Artifact/Noise
THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL: UCTC17GSS BIOPSY INSTRUMENT APPEARED TO BE LARGER THAN OTHER DEVICES OF THE SAME TYPE UNDER MRI. THIS MALFUNCTION WAS REPORTED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED INJURY. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8525184 ↗
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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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