UltraClip® II Breast Tissue Marker 863017Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741032295), received between Mar 15, 2017 and Apr 13, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Device Slipped; Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ULTRASOUND-GUIDED BREAST BIOPSY THROUGH HARD DENSITY TISSUE USING ULTRACLIP TISSUE MARKER DEVICE. DURING THE PROCEDURE, THE DEVICE CLIP COMING LOOSE. NO COAXIAL NEEDLE WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24855944 ↗
• MalfunctionMar 5, 2024Device Slipped; Device Contamination with Chemical or Other Material; Device Slipped; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BREAST TISSUE MARKER PLACEMENT PROCEDURE, A FOREIGN OBJECT WAS ALLEGEDLY FOUND IN A STERILE PACK. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836589 ↗
• MalfunctionMar 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BREAST TISSUE MARKER PLACEMENT PROCEDURE, A SMALL DUST WAS ALLEGEDLY FOUND INSIDE THE DEVICE PACKAGING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18824036 ↗
• MalfunctionDec 27, 2021Poor Quality Image; Therapeutic or Diagnostic Output Failure; Poor Quality Image; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY UNABLE TO BE VIEW IMAGES UNDER ECHOGRAPHY. IT WAS FURTHER REPORTED THAT A PROJECTION OF MAMMOGRAPHY WAS USED TO PROVE THE CLIP LOCATION, BUT IT'S NOT EVIDENCED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13086747 ↗
• 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 6419736 ↗
• 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 6406098 ↗