UltraClip Dual Trigger Breast Tissue MarkerRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 7 models of UltraClip Dual Trigger Breast Tissue Marker by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Dec 22, 2016 and Sep 25, 2026 — classified as 10 injuries, 37 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported UltraClip Dual Trigger Breast Tissue Marker problems
Device problems
- Adverse Event Without Identified Device or Use Problem12
- Device Markings/Labelling Problem10
- Detachment of Device or Device Component6
- Poor Quality Image5
- Component Misassembled4
- Separation Failure4
- Therapeutic or Diagnostic Output Failure4
- Device Contamination with Chemical or Other Material3
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- Hypersensitivity/Allergic reaction5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Consequences Or Impact To Patient2
- Burning Sensation1
- Failure of Implant1
- Injury1
- No Patient Involvement1
UltraClip Dual Trigger Breast Tissue Marker models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- UltraClip® Dual Trigger Breast Tissue Marker 864017DMARKER, RADIOGRAPHIC, IMPLANTABLE20 reports
- UltraClip® Dual Trigger Breast Tissue Marker 863017DMARKER, RADIOGRAPHIC, IMPLANTABLE10 reports
- UltraClip® Dual Trigger Breast Tissue Marker 866017DMARKER, RADIOGRAPHIC, IMPLANTABLE8 reports
- UltraClip® Dual Trigger Breast Tissue Marker 862017DMARKER, RADIOGRAPHIC, IMPLANTABLE4 reports
- UltraClip® Dual Trigger Breast Tissue Marker 864017DLMARKER, RADIOGRAPHIC, IMPLANTABLE3 reports
- UltraClip® Dual Trigger Breast Tissue Marker 863017DLMARKER, RADIOGRAPHIC, IMPLANTABLE2 reports
- UltraClip® Dual Trigger Breast Tissue Marker 862017DLMARKER, RADIOGRAPHIC, IMPLANTABLE1 report
Recent UltraClip Dual Trigger Breast Tissue Marker adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT A MAGNETIC RESONANCE IMAGING GUIDANCE BREAST TISSUE MARKER PLACEMENT PROCEDURE USING THE ULTRACLIP DUAL TRIGGER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT ALLEGEDLY COMPLAINS OF BURNING NEAR THEIR ULTRACLIP DURING AN MRI. HOWEVER, THE CURRENT PATIENT STATUS UNKNOWN.
Patient problems: Burning Sensation
MAUDE report 23836103 ↗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 ↗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 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 ↗InjuryAug 9, 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 PAIN SINCE THE MARKER WAS DEPLOYED. IT WAS FURTHER REPORTED THE SCAR WAS RED AND THE PATIENT ALLEGEDLY FELT ELECTRIC SHOCK SOMETIMES. REPORTEDLY, THE CLIP WAS REMOVED AND THE PAIN WAS SUBSIDED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Pain
MAUDE report 19948235 ↗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 19135128 ↗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 19134900 ↗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 5, 2024Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE MARKER BUTTON ALLEGEDLY SLID TO THE LESION SITE WHERE THE COIL ALLEGEDLY GOT STUCK TO THE NEEDLE WHEN IT WAS RETRACTED FROM THE LESION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18839476 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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