ARTOURA Breast Tissue Expander TEXP120RUHRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00081317009542), received between May 9, 2018 and Jun 26, 2023 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 18, 2026Class IIOpen, Classified

   Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

   Z-1685-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 63-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 535CC ARTOURA BREAST TISSUE EXPANDER PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST IMPLANT BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN UNDISCLOSED DEVICE ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17200335 ↗
• InjuryApr 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 535CC ARTOURA BREAST TISSUE EXPANDER PROSTHESIS. POST-OPERATIVELY, THE PATIENT EXPERIENCED DEFLATION OF THE LEFT BREAST TISSUE EXPANDER. A CONSULTATION WITH A MEDICAL PROFESSIONAL HAS BEEN CONDUCTED. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL AND REPLACEMENT ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16825375 ↗
• InjuryNov 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE WHO UNDERWENT BREAST RECONSTRUCTION WITH A 535CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED DEFLATION POST PROCEDURE. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12902727 ↗
• InjuryJun 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 535CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED RIGHT SIDE EXPANDER DEFLATION POSTOPERATIVELY. AS A RESULT, THE EXPANDER WAS EXPLANTED AND REPLACED WITH CATALOG NUMBER TEXP120RUH; SERIAL NUMBER (B)(4) ON (B)(6) 2021. THE IMPACTED SERIAL NUMBER IS EITHER (B)(4). SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN INFORMATION IS RECEIVED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11952480 ↗
• MalfunctionApr 16, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A 535CC ARTOURA BREAST TISSUE EXPANDER WAS RECEIVED IN A DAMAGED BOX. THE PLASTIC THAT WAS ON THE TISSUE EXPANDER WAS POSSIBLY COMPROMISED. THEREFORE, MENTOR IS CONSERVATIVELY REPORTING THIS EVENT. NO PATIENT CONSEQUENCE OR PROCEDURAL DELAYS WERE REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11682775 ↗
• InjuryMar 19, 2020Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  ONE ARTOURA BREAST TISSUE EXPANDER 535CC WAS RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB ON 2/27/2020 WITH NO ACCOMPANYING INFORMATION. THE DEVICE COULD NOT BE ASSOCIATED WITH AN EXISTING COMPLAINT. IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHY THIS DEVICE WAS RETURNED TO MENTOR. HOWEVER, THE RETURN OF A PROSTHESIS IS CHARACTERISTIC OF A REMOVAL AND REPLACEMENT SURGERY. AS A RESULT, THIS WILL BE CONSERVATIVELY REPORTED TO FDA.

  Patient problems: No Code Available

  MAUDE report 9855920 ↗
• InjuryJul 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH A 535CC ARTOURA BREAST TISSUE EXPANDER AND WAS PRESENTED WITH RIGHT SIDE BREAST IMPLANT DEFLATION AT AN UNKNOWN DATE. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8789022 ↗
• InjuryJan 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH AN ARTOURA BREAST TISSUE EXPANDER 535CC AND EXPERIENCED RIGHT EXPANDER DEFLATION. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8219349 ↗
• InjuryDec 27, 2018Connection Problem; Appropriate Device Problem Term/Code Not Available; Connection Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH A 535CC MENTOR ARTOURA BREAST TISSUE EXPANDER. LEFT TISSUE EXPANDER'S FILL PORT WAS FOUND TO BE DEFECTIVE UPON EXPLANTATION ON (B)(6) 2018 AND WAS REPLACED WITH A 475CC MENTOR MEMORYGEL BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 8200244 ↗
• InjuryNov 14, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH AN ARTOURA BREAST TISSUE EXPANDER 535CC. DEFLATION WAS NOTICED INTRAOPERATIVELY. THE TISSUE EXPANDER WOULD NOT HOLD SUCTION AND THE PROCEDURE WAS DELAYED 45 MINUTES. AS A RESULT, THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8069966 ↗
• InjuryMay 9, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD CAUCASIAN FEMALE UNDERWENT BREAST RECONSTRUCTION WITH 535CC ARTOURA BREAST TISSUE EXPANDERS. ON (B)(6) 2018, THE TISSUE EXPANDERS WERE BEING REMOVED RIGHT SIDED EXPANDER WAS NOTED TO BE COMPLETELY DEFLATION, AND THE LEFT SIDED EXPANDER WAS THOUGHT TO HAVE DEFLATED PARTIALLY. THE TISSUE EXPANDERS WERE THERE REPLACED WITH ANOTHER SET OF 535CC ARTOURA BREAST TISSUE EXPANDERS. THE PATIENT FULLY RECOVERED WITHOUT ANY ADDITIONAL ISSUES. (SEE 1645337-2018-02765 FOR REPORT ON CONTRALATERAL PROSTHESIS).

  Patient problems: No Code Available

  MAUDE report 7501121 ↗
• InjuryMay 9, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD CAUCASIAN FEMALE UNDERWENT BREAST RECONSTRUCTION WITH 535CC ARTOURA BREAST TISSUE EXPANDERS. ON (B)(6) 2018, THE TISSUE EXPANDERS WERE BEING REMOVED RIGHT SIDED EXPANDER WAS NOTED TO BE COMPLETELY DEFLATION, AND THE LEFT SIDED EXPANDER WAS THOUGHT TO HAVE DEFLATED PARTIALLY. THE TISSUE EXPANDERS WERE THERE REPLACED WITH ANOTHER SET OF 535CC ARTOURA BREAST TISSUE EXPANDERS. THE PATIENT FULLY RECOVERED WITHOUT ANY ADDITIONAL ISSUES. (SEE 1645337-2018-02764 FOR REPORT ON CONTRALATERAL PROSTHESIS).

  Patient problems: No Code Available

  MAUDE report 7501118 ↗