Gel Mark Ultra™ Breast Tissue Marker GMUEC10GSSRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741031854), received between Dec 23, 2015 and Nov 7, 2024 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2024Break; Positioning Failure; Poor Quality Image; Material Twisted/Bent; Break; Positioning Failure; Poor Quality Image; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE MARKER WAS ALLEGEDLY NOT PLACED SMOOTHLY. IT WAS FURTHER REPORTED THAT THE INSERTED MARKER CLIP WAS NOT SEEN. FURTHERMORE, THE ENTIRE NEEDLE WAS ALLEGEDLY SKEWED WHEN IT WAS PULLED OUT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20629045 ↗
• InjuryJun 18, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A BREAST BIOPSY MARKER PLACEMENT, THE DEVICE ALLEGEDLY FAILED TO DEPLOY. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. THE PATIENT HAD EXCESSIVE BLEEDING DUE TO MULTIPLE TIME REMOVAL. OF THE DEVICE. THE PATIENT'S CURRENT STATUS WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12023862 ↗
• InjuryJun 3, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO DEPLOY. THE PATIENT HAD EXCESSIVE BLEEDING DUE TO MULTIPLE TIME REMOVAL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT'S CURRENT STATUS WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11929727 ↗
• InjuryMay 9, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT POST BREAST TISSUE MARKER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED AN ALLERGIC REACTION (RASH OVER NECK AND FACE). IT WAS FURTHER REPORTED THAT THE GENERAL PRACTITIONER COMMENCED PREDNISONE. REPORTEDLY, AFTER TESTING, THE IMMUNOLOGIST HAD PREDNISONE CEASED AND ANTIHISTAMINE COMMENCED. IT WAS FURTHER REPORTED THAT THE ANTIHISTAMINE WAS ABLE TO RESOLVE THE REACTION AND THE MARKER REMAINS IN PLACE.

  Patient problems: Rash

  MAUDE report 7501442 ↗
• MalfunctionApr 17, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT POST PLACEMENT OF A BREAST TISSUE MARKER, THE PATIENT ALLEGEDLY HAD EPISODES OF IDIOPATHIC URTICARIA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Urticaria

  MAUDE report 7438655 ↗
• MalfunctionFeb 21, 2018Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT POST BREAST TISSUE MARKER PLACEMENT UNDER STEREOTACTIC GUIDANCE, THE MARKER APPLICATOR TIP WAS NOTED TO HAVE DETACHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287735 ↗
• MalfunctionAug 14, 2017Break; Difficult to Insert; Migration or Expulsion of Device; Difficult to Remove; Activation, Positioning or Separation Problem; Break; Difficult to Insert; Migration or Expulsion of Device; Difficult to Remove; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING BREAST TISSUE MARKER PLACEMENT, THE MARKER APPLICATOR WAS ALLEGEDLY DIFFICULT TO INSERT INTO THE PROBE AND THE MARKER WAS ABLE TO BE PLACED. IT WAS FURTHER REPORTED UNDER POST PROCEDURE IMAGING THE MARKER MIGRATED APPROXIMATELY 1-2 CM FROM THE BIOPSY SITE AND A SMALL FOREIGN OBJECT WAS OBSERVED. REPORTEDLY, THE SMALL PIECE OBSERVED IS A PIECE OF THE MARKER THAT MAY HAVE BROKEN OFF INTO THE PATIENT. IT WAS FURTHER REPORTED THE PROBE AND MARKER WERE REMOVED AS ONE UNIT AND THE MARKER APPLICATOR WAS UNABLE TO BE REMOVED FROM THE PROBE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6792467 ↗
• InjuryDec 23, 2015Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SIX DAYS AFTER A STEREOTACTIC BREAST BIOPSY ON TWO LESIONS IN THE SAME BREAST, THE PATIENT REPORTED SYMPTOMS OF INFECTION WITH A HEMATOMA IN ONE CAVITY AND AN ABSCESS IN THE SECOND. A CULTURE WAS OBTAINED AND TEST RESULTS CONFIRMED PRESENCE OF INFECTION DUE TO STAPHYLOCOCCUS. MEDICAL TREATMENT WAS PROVIDED.

  Patient problems: Staphylococcus Aureus; Unspecified Infection

  MAUDE report 5325422 ↗