UltraClip® II Breast Tissue Marker 864017Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741032301), received between Feb 22, 2017 and Feb 4, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Signal Artifact/Noise” (2 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A BREAST TISSUE MARKER PLACEMENT PROCEDURE USING THE ULTRA CLIP II COIL MARKER. DURING THE PROCEDURE, THE DEVICE PATIENT HAS A NICKEL ALLERGY. FURTHER IT WAS REPORTED TO REMOVE THE MARKER. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24256246 ↗
• InjurySep 30, 2019Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT AFTER PLACEMENT OF THE DEVICE, IT ALLEGEDLY CREATED A SIGNIFICANT ARTIFACT UNDER MRI. IT WAS FURTHER REPORTED THAT THIS ARTIFACT ALLEGEDLY HID THE ENHANCEMENT FROM A SMALL, PREVIOUSLY PLACED, CANCER CLIP. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 9137750 ↗
• MalfunctionOct 9, 2018Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED IN AN ARTICLE IN CLINICAL IMAGING TITLED 'BREAST TISSUE MARKERS: WHY? WHAT'S OUT THERE? HOW DO I CHOOSE?' THAT SOME BREAST TISSUE MARKERS MADE OF STAINLESS STEEL AND BIODUR 108 ARE SUSCEPTIBLE TO CREATING MRI ARTIFACTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7950012 ↗
• MalfunctionMar 20, 2017Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT POST BREAST TISSUE MARKER PLACEMENT INTO NORMAL DENSITY TISSUE, THE MARKER ALLEGEDLY COULD NOT BE SEEN UNDER MAMMOGRAM. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED BY PLACING ANOTHER MARKER AND A COAXIAL WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6419737 ↗
• MalfunctionFeb 22, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE FACILITY RECEIVED A BOX LABELED FOR BREAST TISSUE MARKERS, THE BOX ALLEGEDLY CONTAINED FIVE INDIVIDUAL COAXIAL NEEDLES. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6350000 ↗