UltraClip® Dual Trigger Breast Tissue Marker 862017DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741032219), received between Mar 14, 2017 and Aug 9, 2024 — classified as 3 injuries, 1 malfunction.

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.

• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST A BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED PAIN SINCE THE MARKER WAS DEPLOYED. IT WAS FURTHER REPORTED THE SCAR WAS RED AND THE PATIENT ALLEGEDLY FELT ELECTRIC SHOCK SOMETIMES. REPORTEDLY, THE CLIP WAS REMOVED AND THE PAIN WAS SUBSIDED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Pain

  MAUDE report 19948235 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST A BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED SYSTEMIC REACTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19134900 ↗
• MalfunctionFeb 8, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE, A FOREIGN MATERIAL WAS ALLEGEDLY FOUND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16323746 ↗
• InjuryMar 14, 2017Poor Quality Image; Therapeutic or Diagnostic Output Failure; Poor Quality Image; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT SIX TO EIGHT MONTHS POST BREAST TISSUE MAKER PLACEMENT, THE HEALTH CARE PROVIDER (HCP) WAS UNABLE TO DEMONSTRATE THE EVOLUTION OF THE LESION IN RELATION TO THE MARKER PLACEMENT. IT WAS FURTHER REPORTED THAT AS THE PROGRESSION OF THE CANCER COULD NOT CLEARLY BE IDENTIFIED THE HCP PERFORMED A MASTECTOMY FOR THE END TREATMENT.

  Patient problems: Failure of Implant

  MAUDE report 6402850 ↗