UltraClip® Dual Trigger Breast Tissue Marker 866017DRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741032417), received between Jan 16, 2017 and Sep 23, 2026 — classified as 2 injuries, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  A patient underwent an ultrasound guided marker placement procedure using the UltraClip. Post procedure, the patient reported being recently diagnosed with a nickel allergy and expressed concern that the implanted clips may have contributed to the rashes and other symptoms experienced over the past few years. The current status of the patient was unknown.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50866574 ↗
• MalfunctionMay 20, 2026Break; Positioning Failure

  ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST TISSUE MARKER PLACEMENT PROCEDURE USING THE ULTRACLIP DUAL TRIGGER BREAST TISSUE MARKER. DURING THE PROCEDURE, A FRAGMENT CAME OFF THE CLIP. REPORTEDLY, THERE WAS AN ISSUE WITH MARKER DEPLOYMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25226208 ↗
• MalfunctionMar 4, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST MARKER PLACEMENT PROCEDURE, THE CLIP WAS ALLEGEDLY NOT DEPLOYED. IT WAS FURTHER REPORTED THAT THE CLIP WAS ALLEGEDLY NOT NOTED WHEN THE TECH TOOK THE POST MAMMO IMAGES. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18828191 ↗
• MalfunctionSep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS POST ULTRASOUND GUIDED BREAST TISSUE MARKER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED ALLERGY FLARED UP WITH BURNING SENSATIONS ON HANDS AND ITCHY RASHES DEVELOPED ON SEVERAL PARTS OF BODY. REPORTEDLY, DAILY STEROID CREAMS WERE USED BY THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Hypersensitivity/Allergic reaction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787193 ↗
• MalfunctionMar 20, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE THROUGH, THE MARKER ALLEGEDLY DEPLOYED PREMATURELY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16579134 ↗
• MalfunctionDec 1, 2021Poor Quality Image; Therapeutic or Diagnostic Output Failure; Poor Quality Image; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT POST BREAST MARKER PLACEMENT PROCEDURE, THE MARKER WAS NOT VISIBLE UNDER MAMMOGRAPHY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908320 ↗
• MalfunctionNov 30, 2021Poor Quality Image; Therapeutic or Diagnostic Output Failure; Poor Quality Image; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT POST BREAST TISSUE MARKER PLACEMENT THROUGH HETEROGENEOUSLY DENSITY TISSUE UNDER MAMMOGRAPHY, THE MARKER WAS ALLEGEDLY NOT VISIBLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12891065 ↗
• InjuryJan 16, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT FIVE DAYS POST BREAST TISSUE MARKER PLACEMENT, THE PATIENT ALLEGED A REACTION TO THE MARKER PLACED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD FORMED A RASH ALL OVER THE BODY AND PRESENTED THE REACTION TO THE DOCTOR ELEVEN DAYS AFTER THE PROCEDURE. REPORTEDLY, THIRTEEN DAYS AFTER THE PROCEDURE THE PATIENT WENT TO THE EMERGENCY ROOM AS THE RASH HAS NOT DISSIPATED. THE PATIENT HAD STOPPED TAKING ALL MEDICATIONS AND WAS TAKING ALLERGY MEDICATION TO HELP STOP THE RASH, HOWEVER IT IS STILL PRESENT. IT WAS REPORTED THAT THE PATIENT HAS SCHEDULED AN APPOINTMENT WITH AN ALLERGIST.

  Patient problems: Reaction

  MAUDE report 6254944 ↗