UltraClip® Dual Trigger Breast Tissue Marker 863017DRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741032233), received between Nov 19, 2021 and Sep 25, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2023, a patient underwent an ultrasound guided breast tissue 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 50896537 ↗
• MalfunctionJul 1, 2026Premature Activation; Self-Activation or Keying

  On (b)(6) 2026, a surgeon was preparing to use breast tissue marking cannula on patient using ultra clip dual trigger. Upon opening the package, the surgeon discovered that the cannula had been fired and was unusable. A new breast tissue marking cannula was immediately substituted, and the incident was reported as an adverse event. There was no patient contact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676544 ↗
• MalfunctionOct 8, 2025Nonstandard Device; Self-Activation or Keying; Nonstandard Device; Self-Activation or Keying

  ON (B)(6) 2025, A PATIENT UNDERWENT A MARKER REPLACEMENT BREAST BIOPSY PROCEDURE USING ULTRACLIP DUAL TRIGGER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE WAS DEPLOYED TWO SEPARATE CLIPS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23243110 ↗
• MalfunctionJul 15, 2025Missing Information; Missing Information

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING ULTRACLIP DUAL TRIGGER. PRIOR TO THE PROCEDURE, IT WAS NOTICED THAT BOTH THE EXTERNAL AND INTERNAL PACKAGES WERE MISSING THE MANUFACTURING DATE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505645 ↗
• MalfunctionNov 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE TIP OF THE CLIP WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20618113 ↗
• 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 19135128 ↗
• 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 BREAST TISSUE MARKER PLACEMENT UNDER ULTRASOUND GUIDANCE, THE PATIENT ALLEGEDLY EXPERIENCED ALLERGY FLARED UP WITH BURNING SENSATIONS ON HANDS AND ITCHY RASHES DEVELOPED ON SEVERAL PARTS OF THE 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 17787225 ↗
• MalfunctionSep 8, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO BREAST TISSUE MARKER PLACEMENT PROCEDURE, A HAIR WAS ALLEGEDLY FOUND INSIDE THE STERILE PACKAGING ON THE BIOPSY CLIP. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17710223 ↗
• MalfunctionApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST BREAST MARKER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED PAIN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14039360 ↗
• MalfunctionNov 19, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO A BREAST MARKER PLACEMENT PROCEDURE, THE PACKAGING OF THE DEVICE WAS ALLEGEDLY NOTED TO BE BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844066 ↗