SenoMark® Ultra Breast Tissue Marker SMEC10CRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741032028), received between Apr 28, 2017 and Jul 2, 2026 — classified as 3 injuries, 7 malfunctions.

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

• MalfunctionJul 2, 2026Positioning Failure; Difficult to Remove; Material Deformation

  ON (B)(6) 2026, A PATIENT UNDERWENT A MARKER PLACEMENT PROCEDURE USING THE SENOMARK INSTRUMENT. DURING THE PROCEDURE, THE PHYSICIAN AND TECHNOLOGISTS, THEY SWITCHED TO MARKER MODE ON THE ENCOMPASS AND SELECTED THE 12 O CLOCK POSITION. THEY THEN ALIGNED THE YELLOW ARROW OF THE MARKER WITH THE BUTTON SIDE OF THE DRIVER (1200) AND ATTEMPTED TO DEPLOY THE MARKER BUT ENCOUNTERED RESISTANCE. AN IMAGE WAS TAKEN TO CHECK DEPLOYMENT, BUT NO MARKER WAS VISIBLE WITHIN THE BREAST. THEY ATTEMPTED TO REMOVE THE MARKER AND, PER THE RADIOLOGIST, HAD TO YANK IT OUT OF THE BREAST/NEEDLE AS IT WAS STUCK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25686895 ↗
• MalfunctionApr 28, 2026Break

  ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING A SENOMARK ULTRA BREAST TISSUE MARKER. AFTER THE PROCEDURE, A SMALL PIECE WAS SEEN ALONG THE MARKER TRACK, SIMILAR TO THE TAIL OF THE COIL. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25012825 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO HOURS POST A MAMMOGRAPHY GUIDED BREAST MARKER PLACEMENT PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE PATIENT ALLEGEDLY EXPERIENCED SEVERE PAIN, SWELLING, REDNESS AND TENDERNESS. IT WAS FURTHER REPORTED THAT PAIN RELIEF AND ANTIBIOTICS WERE ADMINISTERED AND THE PATIENT ALLEGEDLY EXPERIENCED MASTITIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Bacterial Infection; Pain; Swelling/ Edema

  MAUDE report 21570524 ↗
• MalfunctionApr 26, 2024Difficult to Insert; Separation Failure; Detachment of Device or Device Component; Material Deformation; Difficult to Insert; Separation Failure; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE CLIP ALLEGEDLY REMAINED ON THE NEEDLE AT THE TIME OF INSERTION. IT WAS FURTHER REPORTED THAT THE CLIP WAS ALLEGEDLY VERY DIFFICULT TO BE INSERTED AND REQUIRED A LOT OF FORCE. REPORTEDLY THE CLIP REMAINED INSIDE THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19189430 ↗
• MalfunctionNov 1, 2023Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE SAMPLES WERE SUCCESSFULLY COLLECTED AND THEN A CRACKLING NOISE BEGAN AT THE STAGE OF QUADVAC. IT WAS FURTHER REPORTED THAT THE MARKER WAS INSERTED WITH MINIMAL RESISTANCE, BUT THE NEEDLE COULD NOT BE RETRACTED, AND A SURGEON WAS CALLED TO ASSIST THE REMOVAL OF THE NEEDLE. THE HCP WAS UNSURE IF A PART OF THE MARKER WAS LEFT IN SITU (I.E., BROKE OFF AT THE TIP OF THE SHEATH) AND WILL BE RETURNING THE DEVICE FOR EVALUATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18045928 ↗
• InjurySep 20, 2022Break; Positioning Failure; Break; Positioning Failure

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

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

  MAUDE report 15456886 ↗
• MalfunctionNov 11, 2021Device Slipped; Component or Accessory Incompatibility; Detachment of Device or Device Component; Device Slipped; Component or Accessory Incompatibility; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO THE MARKER PLACEMENT PROCEDURE, THE PROTECTING CLIP WAS ALLEGEDLY FELL TO THE GROUND. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12791972 ↗
• MalfunctionOct 28, 2020Positioning Failure; Difficult to Remove; Positioning Failure; Difficult to Remove

  THIS REPORT SUMMARIZES THREE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL SMEC10C BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED POSITIONING FAILURE AND DIFFICULT TO REMOVE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THIS MALFUNCTION INVOLVED ALL THREE PATIENTS WITH NO CONSEQUENCES. ONE 50 YEAR OLD FEMALE PATIENT WEIGHT WAS NOT PROVIDED. THE REMAINING TWO PATIENTS AGE, SEX AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10749035 ↗
• InjuryMar 25, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT POST BREAST TISSUE MARKER PLACEMENT THROUGH HARD TISSUE, THE PATIENT ALLEGEDLY EXPERIENCED TOTAL BODY ITCHING. THE DEVICE WAS REMOVED APPROXIMATELY 2 YEARS 4 MONTHS POST IMPLANTATION AND THE PATIENT WAS GIVEN ANTIHISTAMINES. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Itching Sensation

  MAUDE report 9880947 ↗
• MalfunctionApr 28, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT POST BREAST TISSUE MARKER DEPLOYMENT, THE MARKER APPLICATOR ALLEGEDLY HAD A SMALL PLASTIC BEAD ON THE TIP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6530511 ↗