ARTOURA Breast Tissue Expander TEXP130RUHRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00081317009559), received between Oct 2, 2018 and Oct 7, 2024 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR ARTOURA BREAST TISSUE EXPANDER, 650CC SALINE PROSTHESIS EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20390053 ↗
• InjuryDec 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 650CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18411830 ↗
• MalfunctionOct 3, 2023Filling Problem; Filling Problem

  IT WAS REPORTED THAT A 650CC ARTOURA BREAST TISSUE EXPANDER BEING USED IN A PROCEDURE WAS HAVING DIFFICULTY WITH EXPANSION; UPON OPENING THE EXPANDER, IT WAS UNABLE TO BE FILLED. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17863302 ↗
• MalfunctionMar 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A 650CC ARTOURA BREAST TISSUE EXPANDER BEING USED IN A BREAST SURGERY WAS FOUND TO HAVE A BROKEN SUTURE TAB DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS. A BROKEN SUTURE TAB ON A BREAST IMPLANT IS A MALFUNCTION THAT IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. THE MATERIAL FROM WHICH THE TAB IS CONSTRUCTED IS BIOCOMPATIBLE, STERILE, AND NO MORE LIKELY TO CAUSE A TISSUE REACTION THAN A STANDARD BREAST IMPLANT. THE POTENTIAL THAT THIS ISSUE COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT IS REMOTE. HOWEVER, THE BREAST TISSUE EXPANDER WAS RETURNED FOR ANALYSIS ON (B)(6) 2023, AND SEVERAL RENTS WERE OBSERVED WHEN THE INVESTIGATION WAS ULTIMATELY COMPLETED ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550508 ↗
• InjuryMar 15, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 62-YEAR-OLD CAUCASIAN FEMALE WHO HAD A 650CC ARTOURA BREAST TISSUE EXPANDER PLACED EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16550444 ↗
• InjurySep 15, 2022Migration; Migration

  IT WAS REPORTED THAT A 61-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR ARTOURA BREAST TISSUE EXPANDER, 560CC SALINE BREAST IMPLANT EXPERIENCED RIGHT-SIDED DEVICE MIGRATION, CHEST INJURY, BREAST CYST, AND BREAST PAIN POSTOPERATIVELY. THE PATIENT HAD A FALL AND WENT TO THE URGENT CARE SHE SUSPECTS SHE MAYBE HAS A CYST OR AN INGROWN HAIR OR A PIMPLE AND IT WAS LARGE. THE CYST BURST AND IT WAS PAINFUL. THE PATIENT HAD AN XRAY, AND THE HOSPITAL NOTIFIED THE PATIENT THAT EVERYTHING IS OK. SHE ALSO FELT THAT HER IMPLANT IS COMING OUT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Breast Discomfort/Pain; Cyst(s)

  MAUDE report 15431053 ↗
• InjuryJun 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH AN ARTOURA BREAST TISSUE EXPANDER 650CC DEVICE THAT DEFLATED AFTER IMPLANTATION. THE PATIENT NOTICED THAT HER RIGHT BREAST WAS FLAT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN ARTOURA BREAST TISSUE EXPANDER 650CC DEVICE ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8667369 ↗
• InjuryMay 30, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 650CC ARTOURA BREAST TISSUE EXPANDER ON THE LEFT SIDE, SUFFERED LEAKING POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8655937 ↗
• InjuryApr 29, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR ARTOURA 650CC BREAST TISSUE EXPANDER THAT DEFLATED POSTOPERATIVELY. ON (B)(6) 2019, DURING SURGERY TO REMOVE THE DEVICE, A HOLE WAS IDENTIFIED ON THE JUNCTION PATCH NEAR THE FILLING PORT.

  Patient problems: No Code Available

  MAUDE report 8562989 ↗
• InjuryOct 2, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH AN ARTOURA BREAST TISSUE EXPANDER 650CC AND EXPERIENCED DEFLATION ON THE RIGHT SIDE. DEFLATION WAS DIAGNOSED BY A DOCTOR¿S VISUAL EXAMINATION DURING EXPLANTATION ON (B)(6)2018. THE DEVICE WAS REPLACED WITH A MENTOR INSPIRA SMOOTH RD GEL BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 7927044 ↗