SenoMark Ultra Breast Tissue MarkerRecalls & reported problems across all models

We found 8 models of SenoMark Ultra Breast Tissue Marker by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 46 adverse event reports in the FDA's MAUDE database, received between Dec 4, 2015 and Jul 2, 2026 — classified as 9 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (17 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

Most reported SenoMark Ultra Breast Tissue Marker problems

SenoMark Ultra Breast Tissue Marker models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SenoMark® Ultra Breast Tissue Marker SMEC10R

  MARKER, RADIOGRAPHIC, IMPLANTABLE
  24 reports
• SenoMark® Ultra Breast Tissue Marker SMEC10C

  MARKER, RADIOGRAPHIC, IMPLANTABLE
  10 reports
• SenoMark® Ultra Breast Tissue Marker SMMA11R

  MARKER, RADIOGRAPHIC, IMPLANTABLE
  4 reports
• SenoMark® Ultra Breast Tissue Marker SMAT9C

  MARKER, RADIOGRAPHIC, IMPLANTABLE
  3 reports
• SenoMark® Ultra Breast Tissue Marker SMEV9R

  MARKER, RADIOGRAPHIC, IMPLANTABLE
  2 reports
• SenoMark® Ultra Breast Tissue Marker SMEC7C

  MARKER, RADIOGRAPHIC, IMPLANTABLE
  1 report
• SenoMark® Ultra Breast Tissue Marker SMEC7R

  MARKER, RADIOGRAPHIC, IMPLANTABLE
  1 report
• SenoMark® Ultra Breast Tissue Marker SMEC12R

  MARKER, RADIOGRAPHIC, IMPLANTABLE
  1 report

Recent SenoMark Ultra 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.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 10, 2026Component Missing; Device Contamination with Chemical or Other Material

  ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST TISSUE MARKER PLACEMENT PROCEDURE BY USING THE SENO MARK ULTRA. IT WAS REPORTED THAT PRIOR THE PROCEDURE, THE STERILE DEVICE WAS ALLEGEDLY OPENED AND FOUND TO BE MISSING ITS PROTECTIVE CAP. THERE WAS NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24302050 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE MONTHS POST BREAST TISSUE MARKER PLACEMENT, THE PATIENT EXPERIENCED WEIRD SENSATION, RASHES IN THE CHEST AREA AND ABDOMEN WITH ASSOCIATED NAUSEA. IT WAS FURTHER REPORTED THAT THE PATIENT HAS HAD THE MARKER IN PLACE FOR ONE AND HALF A YEAR. HOWEVER, THE PATIENT DID NOT UNDERWENT ANY MEDICAL INTERVENTION NOR MEDICATIONS PRESCRIBED FOR RASHES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Hypersensitivity/Allergic reaction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225742 ↗
• 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 ↗
• 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 ↗

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