ARTOURA Breast Tissue Expander TEXP155RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00081317009511), received between Dec 18, 2019 and Dec 23, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Material Rupture” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION WITH MENTOR ARTOURA BREAST TISSUE EXPANDER, 850CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST OPERATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REPLACEMENT WITH LOT: 2055391 ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23881351 ↗
• InjuryMay 26, 2023Material Rupture; Use of Device Problem; Defective Device; Material Rupture; Use of Device Problem; Defective Device

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH AN ARTOURA BREAST TISSUE EXPANDER 850CC WHICH WAS REPORTEDLY DEFECTIVE DURING EXPANSION. NO SPECIFIC FAILURE MODE WAS PROVIDED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17012207 ↗
• InjuryJun 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH AN 850CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021 .

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11971284 ↗
• InjuryDec 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A 850CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED POSTOPERATIVE BILATERAL DEFLATION. HCP REPORTED LEAKING DURING THE LAST FEW FILLS AND NEEDED TO FILL THE TISSUE EXPANDER MORE TO ACCOMMODATE FOR THE LEAKING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR TISSUE EXPANDER 1 OF 2.

  Patient problems: No Code Available

  MAUDE report 9490347 ↗
• InjuryDec 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A 850CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED POSTOPERATIVE BILATERAL DEFLATION. HCP REPORTED LEAKING DURING THE LAST FEW FILLS AND NEEDED TO FILL THE TISSUE EXPANDER MORE TO ACCOMMODATE FOR THE LEAKING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR TISSUE EXPANDER 2 OF 2.

  Patient problems: No Code Available

  MAUDE report 9490345 ↗