UltraClip® Dual Trigger Breast Tissue Marker 864017DRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741032257), received between Dec 22, 2016 and Sep 23, 2025 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2025Difficult to Remove; Separation Failure; Difficult to Remove; Separation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BREAST TISSUE MARKER PLACEMENT PROCEDURE USING THE ULTRACLIP DUAL TRIGGER VIA PERCUTANEOUS PUNCTURE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE TUBE WAS ALLEGEDLY CLAMPED THE TISSUE. DURING WITHDRAWAL, IT WAS FURTHER REPORTED THAT THE TISSUE AND THE MARKER WAS REMOVED TOGETHER. NO COAXIAL BIOPSY NEEDLE 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 23121066 ↗
• MalfunctionJul 26, 2024Positioning Failure; Separation Failure; Detachment of Device or Device Component; Positioning Failure; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING BIOPSY PROCEDURE, THE CLIP WAS ALLEGEDLY FAILED TO DEPLOY WHILE PUSHED DOWN. IT WAS FURTHER REPORTED THAT PUSH BUTTON WAS ALLEGEDLY POPPED OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19835891 ↗
• 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 19134899 ↗
• MalfunctionMar 4, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST MARKER PLACEMENT PROCEDURE, THE COIL CLIP WAS ALLEGEDLY NOT DEPLOYED. IT WAS FURTHER REPORTED THAT THE PHYSICIAN COULD SEE THE CLIP DEPLOYING ON THE ULTRASOUND CINE BUT ALLEGEDLY COULDN'T SEE IT ON THE POST CLIP MAMMO. A 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 18828323 ↗
• MalfunctionJun 27, 2023Device Markings/Labelling Problem; Component Misassembled; Device Markings/Labelling Problem; Component Misassembled

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE DEPLOYED MARKER WAS ALLEGEDLY DIFFERENT SHAPED CLIP THAN THE ONE THAT WAS MENTIONED IN THE LABEL. IT WAS FURTHER REPORTED THAT IT SHOULD HAVE BEEN A COIL SHAPED MARKER BUT THE DEPLOYED MARKER IS A PADLOCK SHAPED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17206877 ↗
• MalfunctionJun 26, 2023Device Markings/Labelling Problem; Component Misassembled; Device Markings/Labelling Problem; Component Misassembled

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE DEPLOYED TISSUE MARKER WAS ALLEGEDLY A DIFFERENT SHAPED CLIP THAN THE ONE THAT WAS MENTIONED IN THE LABEL. IT WAS FURTHER REPORTED THAT IT SHOULD HAVE BEEN A COIL SHAPED MARKER BUT THE DEPLOYED MARKER WASS A PADLOCK SHAPED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17198798 ↗
• MalfunctionJun 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE, WHEN THE HANDLE IS PICKED UP, THE FRONT-END POSITIONING CLIP WAS ALLEGEDLY FALLEN OFF. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17142509 ↗
• MalfunctionJun 15, 2023Device Markings/Labelling Problem; Component Misassembled; Device Markings/Labelling Problem; Component Misassembled

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE DEPLOYED MARKER WAS ALLEGEDLY DIFFERENT SHAPED CLIP THAN THE ONE THAT WAS MENTIONED IN THE LABEL. IT WAS FURTHER REPORTED THAT IT SHOULD HAVE BEEN A COIL SHAPED MARKER BUT THE DEPLOYED MARKER IS A PADLOCK SHAPED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17133482 ↗
• MalfunctionJun 13, 2023Device Markings/Labelling Problem; Component Misassembled; Device Markings/Labelling Problem; Component Misassembled

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE DEPLOYED MARKER WAS ALLEGEDLY DIFFERENT SHAPED CLIP THAN THE ONE THAT WAS MENTIONED IN THE LABEL. IT WAS FURTHER REPORTED THAT IT SHOULD HAVE BEEN A COIL SHAPED MARKER BUT THE DEPLOYED MARKER IS A PADLOCK SHAPED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17115474 ↗
• MalfunctionSep 5, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE MARKER COMPONENTS WERE ALLEGEDLY DISASSEMBLED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15354813 ↗
• MalfunctionSep 5, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE MARKER COMPONENTS WERE ALLEGEDLY DISASSEMBLED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15354352 ↗
• MalfunctionJul 23, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE UNDER ULTRASOUND GUIDANCE, THE MARKER COMPONENTS WERE ALLEGEDLY DISASSEMBLED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090266 ↗
• MalfunctionJul 22, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE UNDER ULTRASOUND GUIDANCE, THE MARKER COMPONENTS WERE ALLEGEDLY DISASSEMBLED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15081467 ↗
• MalfunctionApr 19, 2022Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE CLIP WAS ALLEGEDLY DETACHED FROM THE SUPPORT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14139795 ↗
• MalfunctionJan 19, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING PLACEMENT OF A BREAST TISSUE MARKER, THE MARKER COMPONENTS WERE ALLEGEDLY MISASSEMBLED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289242 ↗
• MalfunctionJan 18, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE MARKER COMPONENTS WERE ALLEGEDLY MISASSEMBLED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13273734 ↗
• InjuryMar 12, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO WEEKS AFTER PLACEMENT OF A BREAST TISSUE MARKER, THE PATIENT ALLEGEDLY DEVELOPED ITCHING ALL OVER AND PAIN AT THE IMPLANTATION SITE. IT WAS FURTHER REPORTED THAT THE DEVICE HAD TO BE SURGICALLY REMOVED. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 9822391 ↗
• MalfunctionOct 21, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 864017D BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED PATIENT-DEVICE INCOMPATIBILITY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS FEMALE; AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9214215 ↗
• MalfunctionJul 12, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 864017D ULTRACLIP DT MARKER ALLEGEDLY HAD FOREIGN MATERIAL PRESENT IN DEVICE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED FOREIGN MATERIAL PRESENT IN DEVICE DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8785888 ↗
• Dec 22, 2016Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT POST TISSUE MARKER PLACEMENT UNDER MRI IMAGING, THERE ALLEGEDLY WAS A BLOOMING ARTIFACT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6198723 ↗