ARTOURA Breast Tissue Expander TEXP110RUHRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00081317009535), received between Mar 12, 2020 and Feb 23, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 31-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 455CC ARTOURA BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT EXPERIENCED NEUROLOGICAL DAMAGE, TISSUE DEATH, BONE EROSION, HAIR LOSS, SKIN RASH, SHORTNESS OF BREATH, LOSS OF VISION, HEADACHES, PARALYSIS, FUNGAL INFECTION, DEPRESSION, ANXIETY, ATTENTION-DEFICIT/HYPERACTIVITY DISORDER, FOREIGN BODY GRANULES, DENTAL ISSUES, UNEXPLAINED FILM ALL OVER THE BODY, GREEN/GREY COLORATION ALL OVER BODY, SORES, METALLIC SMELLS/TASTE, SHINGLES, DERMATITIS, AND OTITIS EXTERNA. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH UNDISCLOSED BREAST IMPLANTS ON (B)(6) 2022. THE DATE OF EVENT WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-02017 FOR THE CONTRALATERAL EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Post Operative Wound Infection

  MAUDE report 16428692 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 31-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 455CC ARTOURA BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT EXPERIENCED NEUROLOGICAL DAMAGE, TISSUE DEATH, BONE EROSION, HAIR LOSS, SKIN RASH, SHORTNESS OF BREATH, LOSS OF VISION, HEADACHES, PARALYSIS, FUNGAL INFECTION, DEPRESSION, ANXIETY, ATTENTION-DEFICIT/HYPERACTIVITY DISORDER, FOREIGN BODY GRANULES, DENTAL ISSUES, UNEXPLAINED FILM ALL OVER THE BODY, GREEN/GREY COLORATION ALL OVER BODY, SORES, METALLIC SMELLS/TASTE, SHINGLES, DERMATITIS, AND OTITIS EXTERNA. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH UNDISCLOSED BREAST IMPLANTS ON (B)(6) 2022. THE DATE OF EVENT WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-02018 FOR THE CONTRALATERAL EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Post Operative Wound Infection

  MAUDE report 16428690 ↗
• MalfunctionMar 12, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 455CC ARTOURA BREAST TISSUE EXPANDER BEGAN LEAKING DURING A PRIMARY BREAST RECONSTRUCTION. THE DEVICE WAS OPENED ON THE SURGICAL TABLE AND SLIGHTLY FILLED; HOWEVER, THE DEVICE BEGAN TO LEAK. AT THE TIME OF THIS REPORT, THERE IS NO EVIDENCE OF A NEED FOR ADDITIONAL SURGICAL INTERVENTION, BUT A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9824504 ↗