SenoMark® Ultra Breast Tissue Marker SMEC10RRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741032035), received between Feb 27, 2017 and Jun 15, 2026 — classified as 5 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Positioning Failure; Difficult to Insert; Difficult to Remove

  On (b)(6), 2026, a patient underwent marker placement procedure using the SenoMark instrument. During the procedure, it was noticed that the marker clip could not be placed due to the inability to fully insert the shaft into the cannula. As a result, the device was removed without clip placement and it was not possible to remove the clip release mechanism from the canula. Front and lateral X-rays were taken to verify that calcifications remained to serve as landmarks. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498420 ↗
• InjurySep 2, 2025Difficult to Insert; Difficult to Insert

  ON (B)(6) 2025, A PATIENT UNDERWENT A BREAST BIOPSY PROCEDURE WITH THE ENCOR PROBE AND MARKER PLACEMENT WITH A SENORMARK ULTRA. DURING THE PROCEDURE, A CLICK SOUND WAS HEARD DURING VACUUMING AND THE PATIENT FELT PAIN. THE DEVICE WAS NOT FULLY CLOSED, AND AN OBSTRUCTION WAS FELT. THE MARKER WAS SUCCESSFULLY DEPLOYED. HOWEVER, THE PROVED WAS NOT FULLY CLOSED AFTER REMOVAL. IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING SIGNIFICANT BLEEDING, AND A LARGE HEMATOMA WAS PRESENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 22931668 ↗
• InjuryJun 25, 2025Difficult to Remove; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT A STEREOTACTIC GUIDED BREAST BIOPSY AND MARKER PLACEMENT PROCEDURE USING VIA FATTY DENSITY TISSUE THE ENCOR PROBE WITH SENOMARK ULTRACOR MARKER. DURING THE PROCEDURE, A CLIP IS INSERTED AND SUBSEQUENTLY CANNOT BE REMOVED. THE CLIP GUIDE AND THE ENTIRE NEEDLE BECOME STUCK IN THE PATIENT'S BREAST. FURTHER IT WAS REPORTED THAT A LARGER INCISION WAS MADE AT THE NEEDLE ENTRY SITE. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 22326186 ↗
• MalfunctionMay 26, 2025Positioning Failure; Difficult to Insert; Difficult to Remove; Positioning Failure; Difficult to Insert; Difficult to Remove

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ELECTRON-TRIGGERED X-RAY IMAGING BREAST TISSUE MARKER PLACEMENT PROCEDURE THROUGH GREASE DENSITY TISSUE USING SENOMARK ULTRA AND ENCOR PROBE. DURING THE PROCEDURE, THE MARKER WAS ALLEGEDLY DIFFICULT TO INSERT INTO THE PROBE. IT WAS FURTHER REPORTED THAT THE MARKER FAILED TO DEPLOY. AFTER WASHING AND PLACING THE MARKER ON THE NEEDLE, THE MARKER DID NOT COME OUT OF THE GUIDE, REMAINING HALFWAY OPEN, WHICH MADE IT DIFFICULT TO REMOVE THE NEEDLE FROM THE BREAST. REPORTEDLY NEEDLE WAS REMOVED WITH THE HELP OF AN EMERGENCY SURGEON, BY MAKING A LARGER INCISION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22083149 ↗
• MalfunctionMay 26, 2025Positioning Failure; Difficult to Insert; Difficult to Remove; Positioning Failure; Difficult to Insert; Difficult to Remove

  ON APRIL 24, 2025, A PATIENT UNDERWENT AN ELECTRON-TRIGGERED X-RAY IMAGING BREAST TISSUE MARKER PLACEMENT PROCEDURE THROUGH GREASE DENSITY TISSUE USING SENOMARK ULTRA AND ENCOR PROBE. DURING THE PROCEDURE, THE MARKER WAS ALLEGEDLY DIFFICULT TO INSERT INTO THE PROBE. IT WAS FURTHER REPORTED THAT THE MARKER FAILED TO DEPLOY. AFTER WASHING AND PLACING THE MARKER ON THE NEEDLE, THE MARKER DID NOT COME OUT OF THE GUIDE, REMAINING HALFWAY OPEN, WHICH MADE IT DIFFICULT TO REMOVE THE NEEDLE FROM THE BREAST. REPORTEDLY NEEDLE WAS REMOVED WITH THE HELP OF AN EMERGENCY SURGEON, BY MAKING A LARGER INCISION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22083139 ↗
• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED THAT DURING BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE MARKER ALLEGEDLY SPLIT INTO TWO PIECES DURING USE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21430157 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST A BREAST TISSUE MARKER PLACEMENT, THE PATIENT EXPERIENCED AN ANAPHYLACTIC ALLERGY TO POLYETHYLENE GLYCOL AND WAS ADMINISTERED ADRENALINE. IT WAS FURTHER REPORTED THAT THE PHYSICIAN PLANNED TO REMOVE THE MARKER AND THE POLYGLYCOLIC ACID PADS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20221878 ↗
• MalfunctionJul 22, 2024Component or Accessory Incompatibility; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE MARKER ALLEGEDLY DID NOT GO THROUGH THE WHITE GUIDE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791473 ↗
• MalfunctionJul 9, 2024Improper or Incorrect Procedure or Method; Component or Accessory Incompatibility; Improper or Incorrect Procedure or Method; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE APPLICATOR ALLEGEDLY COULD NOT BE INSERTED THROUGH THE TIP GUIDE. 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 19707730 ↗
• MalfunctionNov 2, 2023Difficult to Remove; Separation Failure; Difficult to Remove; Separation Failure

  IT WAS REPORTED THAT DURING A BIOPSY BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE CLIP WAS ALLEGEDLY NOT DISPLAYED ON THE CONTROL MAMMOGRAM AND JAM OCCURRED BETWEEN THE NEEDLE OPENING AND THE CLIP DEVICE THUS THE NEEDLE WAS TRIED TO BE REMOVED MANUALLY. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY FELT PAIN AND DISCOMFORT SINCE RESISTANCE WAS DEVELOPED WHEN TRYING TO REMOVE THE NEEDLE. REPORTEDLY, A NEW IMAGE WAS TAKEN WHERE THE CLIP WAS NOT VISIBLE, WHICH ALLEGEDLY REMAINED AT THE TIP OF THE THE NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18054293 ↗
• MalfunctionJul 13, 2023Positioning Failure; Difficult to Remove; Positioning Failure; Difficult to Remove

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE MARKER ALLEGEDLY FAILED TO BE DEPLOYED. IT WAS FURTHER REPORTED THAT THERE WAS RESISTANCE FELT AND THE MARKER FAILED TO BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315337 ↗
• InjuryFeb 20, 2023Poor Quality Image; Difficult to Remove; Poor Quality Image; Difficult to Remove

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST BREAST MARKER PLACEMENT PROCEDURE, THE MARKER WAS ALLEGEDLY NOT VISIBLE UNDER ULTRASOUND WHILE THE SURGERY OF REMOVING CALCIFIED LESION AND ITS BREAST MARKER. IT WAS FURTHER REPORTED THAT TISSUE MARKER COULD NOT BE REMOVED FROM PATIENT. REPORTEDLY, SURGERY WAS PERFORMED TO REMOVE ITS MARKER, BUT COULD NOT REMOVE. IT WAS CONSIDERED THAT TISSUE MARKER IS REMAINED IN THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 16403686 ↗
• MalfunctionNov 7, 2022Break; Device Contamination with Chemical or Other Material; Break; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT POST BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15742418 ↗
• MalfunctionAug 29, 2022Poor Quality Image; Therapeutic or Diagnostic Output Failure; Poor Quality Image; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT MAMMOGRAPHY UNIT X-RAY GUIDED POST BREAST TISSUE MARKER PLACEMENT PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE MARKER WAS ALLEGEDLY NOT SEEN ON THE IMAGING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15309096 ↗
• MalfunctionApr 12, 2022Component Missing; Separation Failure; Component Misassembled; Component Missing; Separation Failure; Component Misassembled

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST MARKER PLACEMENT PROCEDURE, THE MARKER FAILED TO RELEASE INTO THE CAVITY AND CAME ALONG WITH THE NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083528 ↗
• MalfunctionJul 22, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A BREAST BIOPSY MARKER PLACEMENT PROCEDURE, THE MARKER WAS ALLEGEDLY DIFFICULT TO REMOVE FROM THE BIOPSY PROBE AND IN THE END A PIECE OF PLASTIC THAT PROTRUDED THROUGH THE BIOPSY CHAMBER WAS CUT OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12210146 ↗
• MalfunctionMay 28, 2021Break; Positioning Failure; Difficult to Remove; Detachment of Device or Device Component; Break; Positioning Failure; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE ALLEGEDLY HAD A POSITIONING FAILURE AND THE DEVICE WAS DIFFICULT TO BE REMOVED AFTER THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11899699 ↗
• MalfunctionOct 16, 2019Poor Quality Image; Poor Quality Image

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL SMEC10R BIOPSY MARKER ALLEGEDLY PRODUCED A POOR QUALITY IMAGE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ONE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT IS 76 KGS, FEMALE BUT THE AGE WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9200138 ↗
• MalfunctionOct 16, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING PLACEMENT OF A BREAST TISSUE MARKER, A TUBULAR, PAPER-LIKE MATERIAL ALLEGEDLY WAS FOUND UPON REMOVAL OF THE MARKER APPLICATOR FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE MARKER WAS NOT DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7970882 ↗
• MalfunctionOct 16, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING PLACEMENT OF A BREAST TISSUE MARKER, A TUBULAR, PAPER-LIKE MATERIAL ALLEGEDLY WAS FOUND UPON REMOVAL OF THE MARKER APPLICATOR FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE MARKER WAS SUCCESSFULLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7970655 ↗
• MalfunctionOct 16, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING PLACEMENT OF A BREAST TISSUE MARKER, A TUBULAR, PAPER-LIKE MATERIAL ALLEGEDLY WAS FOUND UPON REMOVAL OF THE MARKER APPLICATOR FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE MARKER WAS SUCCESSFULLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7970450 ↗
• MalfunctionSep 18, 2018Positioning Failure; Difficult to Remove; Detachment of Device or Device Component; Positioning Failure; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREPARATION OF A STEREOTACTIC BREAST BIOPSY, THE DEVICE ALLEGEDLY WAS OBSERVED TO BE BENT. IT WAS FURTHER REPORTED THAT AN ATTEMPT WAS MADE TO DEPLOY THE DEVICE AND IT ALLEGEDLY FAILED TO DEPLOY AND WAS DIFFICULT TO REMOVE FROM THE APPLICATOR. THE PROCEDURE WAS CONCLUDED WITHOUT ANY MARKER PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7887718 ↗
• InjuryJul 20, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT POST BREAST TISSUE MARKER PLACEMENT, THE PATIENT ALLEGEDLY HAD AN ALLERGIC REACTION OF SWELLING AND RASH AROUND THE AREA. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TREATED WITH ANTIBIOTICS. REPORTEDLY, A FEW MONTHS LATER THE MARKER WAS REMOVED DURING A SCHEDULED LUMPECTOMY, FOLLOWING THE LUMPECTOMY THE SWELLING AND RASH WENT AWAY AND HAVE NOT RETURNED.

  Patient problems: Reaction

  MAUDE report 6730514 ↗
• MalfunctionFeb 27, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER COMPLETING BREAST TISSUE MARKER PLACEMENT, THERE WAS ALLEGEDLY FOREIGN WHITE MATERIAL FOUND ON THE TIP OF THE PROBE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6362360 ↗