ULTRACOR TWIRL UCTW17Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741109416), received between Dec 19, 2017 and May 22, 2026 — classified as 7 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, a patient underwent a breast biopsy procedure using an UltraCor Twirl Breast Tissue Marker. Following marker placement, it was reported that the patient experienced an adverse tissue reaction. The patient subsequently developed a rash, which began later on the evening of the procedure and progressively spread beyond the breast area. The patient also reported generalized itching radiating from the breast to other areas of the body. Medical intervention was sought, and steroid therapy was prescribed by the treating physician. The patient additionally used homeopathic creams, diphenhydramine (Benadryl), and loratadine (Claritin); however, these measures reportedly provided limited symptom relief. The patient reported a history of a few food allergies but no other relevant allergies were identified. The patient's current status is unknown.

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

  MAUDE report 25251202 ↗
• MalfunctionFeb 10, 2026Break

  ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST MARKER PROCEDURE BY USING ULTRACOR TWIRL BREAST TISSUE MARKER. IT WAS REPORTED THAT POST PROCEDURE MAMMOGRAPHIC IMAGING SHOWED THAT THE MARKER WAS ALLEGEDLY FRAGMENTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301763 ↗
• MalfunctionSep 26, 2025Positioning Failure; Difficult to Remove; Separation Failure; Positioning Failure; Difficult to Remove; Separation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT A BREAST TISSUE MARKER PLACEMENT PROCEDURE THROUGH NORMAL DENSITY TISSUE USING THE ULTRACOR TWIRL BREAST TISSUE MARKER. DURING THE PROCEDURE, THE CLIP DID NOT DETACH FROM THE INSERTION DEVICE AFTER DEPLOYMENT. IT REMAINED ATTACHED AT THE TIP AND PULLED THROUGH BREAST TISSUE DURING REMOVAL, CAUSING SIGNIFICANT PAIN. THE CLIP ENDED UP APPROXIMATELY 2 CM FROM THE BIOPSY SITE. IT WAS FURTHER REPORTED THAT PRESSURE REQUIRED TO DEPRESS THE PLUNGER. THE PATIENT EXPERIENCED PAIN AND DISTRESS DUE TO THE DRAGGING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23152111 ↗
• MalfunctionNov 26, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE, THERE WAS A HAIR ALLEGEDLY FOUND INSIDE THE PACKAGING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785149 ↗
• MalfunctionMay 14, 2024Break; Break

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE MARKER WAS ALLEGEDLY BROKEN AND CAUSED BITS OF NITINOL TO BE SHAVED OFF THE MARKER DURING ASPIRATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19307494 ↗
• MalfunctionMay 15, 2023Premature Activation; Device Misassembled During Manufacturing /Shipping; Premature Activation; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST MARKER PLACEMENT PROCEDURE, THE DEVICE WAS ALLEGEDLY IN THE UNLOCK POSITION WHEN THE NEEDLE WAS STILL IN THE PACKAGE. IT WAS FURTHER REPORTED THAT THE MARKER WAS STILL USED ON PATIENT AND MADE DIFFICULT TO KNOW IF THE MARKER WAS IN THE NEEDLE AS IF IT WAS ALREADY UNLOCKED. NO COAXIAL WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929312 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST BREAST TISSUE MARKER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED GIANT MAMMARY URTICARIA. IT WAS FURTHER REPORTED THE ADDITIONAL MEDICATION WAS PROVIDED AND THE CLIPS WERE NOT REMOVED YET. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16321609 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST BREAST TISSUE MARKER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED GIANT MAMMARY URTICARIA. IT WAS FURTHER REPORTED THE ADDITIONAL MEDICATION WAS PROVIDED AND THE CLIPS WERE NOT REMOVED YET. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16321547 ↗
• MalfunctionFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER PLACEMENT, THE PATIENT EXPERIENCED ALLERGIES AND RASHES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16316197 ↗
• MalfunctionJun 8, 2022Difficult to Remove; Improper or Incorrect Procedure or Method; Separation Failure; Difficult to Remove; Improper or Incorrect Procedure or Method; Separation Failure

  IT WAS REPORTED THAT DURING A VACUUM ASSISTED BREAST BIOPSY PROCEDURE, THE MARKER ALLEGEDLY GOT STUCK IN THE PROBE. IT WAS FURTHER REPORTED THAT THE MARKER WAS NEAR TO THE SURFACE OF THE SKIN AND CAUSED SOME PAIN. REPORTEDLY, THE PROBE WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14629986 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREAST MARKER PLACEMENT PROCEDURE, THE PATIENT WAS ALLEGEDLY HAD MORE PAIN WHEN INSERTING A MARKER. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 13496462 ↗
• MalfunctionMay 11, 2021Difficult to Remove; Separation Failure; Material Twisted/Bent; Difficult to Remove; Separation Failure; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BREAST MARKER PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806673 ↗
• MalfunctionJul 16, 2020Material Discolored; Material Twisted/Bent; Material Discolored; Material Twisted/Bent

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL UCTW17 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED BENT NEEDLE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT CONTACT. THE PATIENT'S AGE AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10282990 ↗
• InjuryMay 20, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT AFTER PLACEMENT OF BREAST TISSUE MARKER, THE PATIENT ALLEGEDLY EXPERIENCED REDNESS AND SWELLING AT THE INSERTION SITE. THE DEVICE HAS NOT BEEN REMOVED BUT IS SCHEDULED TO BE REMOVED AT A LATER DATE. THE CURRENT PATIENT'S STATUS IS UNKNOWN.

  Patient problems: Reaction

  MAUDE report 10077202 ↗
• MalfunctionApr 14, 2020Material Discolored; Device Contamination with Chemical or Other Material; Material Twisted/Bent; Material Discolored; Device Contamination with Chemical or Other Material; Material Twisted/Bent

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL UCTW17, BREAST TISSUE MARKER, ALLEGEDLY EXPERIENCED BENT MATERIAL, AND FOREIGN MATERIAL PRESENT IN THE DEVICE.THIS INFORMATION WAS RECIEVED FROM A SINGLE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT. THE DEVICE WAS USED IN A FEMALE PATIENT, HOWEVER AGE, AND WEIGHT DETAILS WAS NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9957865 ↗
• InjuryJan 3, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST TISSUE MARKER PLACEMENT PROCEDURE INTO HARD TISSUE, THE DEVICE ALLEGEDLY WAS FOUND TO BE POTENTIALLY INCOMPATIBLE WITH THE PATIENT. IT WAS FURTHER REPORTED THAT UPON TEST RESULTS TWO WEEKS POST PROCEDURE, IT WAS DISCOVERED THE PATIENT WAS ALLEGEDLY ALLERGIC TO A COMPONENT OF THE DEVICE. A COAXIAL WAS USED DURING THE PROCEDURE AND THE PROCEDURE WAS COMPLETED BY USING THE SAME MARKER. THE PATIENT WAS REPORTEDLY STABLE AND WILL HAVE THE MARKER SURGICALLY REMOVED.

  Patient problems: Reaction

  MAUDE report 9545998 ↗
• MalfunctionMay 30, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE NEEDLE OF THE BREAST TISSUE MARKER ALLEGEDLY PIERCED THROUGH THE PACKAGING. THERE WAS NO PATIENT OR USER CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7555170 ↗
• InjuryDec 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A BREAST TISSUE MARKER DEPLOYMENT PROCEDURE, THE MARKER ALLEGEDLY CAUSED ARTERIAL BLEEDING IN THE PATIENT.

  Patient problems: Blood Loss

  MAUDE report 7130441 ↗