ARTOURA Breast Tissue Expander TEXP135RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00081317009481), received between Jul 25, 2018 and Sep 21, 2023 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 63-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 500CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17790001 ↗
• MalfunctionJun 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 500CC ARTOURA BREAST TISSUE EXPANDER BEING USED FOR A PRIMARY BREAST RECONSTRUCTION DEFLATED INTRAOPERATIVELY. A HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS A HOLE ON THE EXPANDER THAT WAS NOT NEAR THE SUTURE LINE. THE HOLE WAS NOTICED DURING THE IMPLANTATION SURGERY, AND THE DEVICE HAD TOUCHED THE PATIENT. HOWEVER, AT THIS TIME OF REPORT, NO PATIENT CONSEQUENCES OR PROCEDURAL DELAYS WERE REPORTED DUE TO THE DEFLATION. THE IMPLANTATION SURGERY WAS COMPLETED WITH USING AN UNSPECIFIED MENTOR DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10121113 ↗
• MalfunctionApr 14, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A BREAST AUGMENTATION PROCEDURE, AN ARTOURA BREAST TISSUE EXPANDER 500CC DEFLATED INTRAOPERATIVELY. THERE WERE NO REPORTED ADVERSE EVENTS AND THERE WERE NO DELAYS IN SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9960307 ↗
• InjuryOct 22, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH ARTOURA BREAST TISSUE EXPANDER 500CC AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9218903 ↗
• InjurySep 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH UNKNOWN NAME, RACE, SEX, AND GENDER UNDERWENT UNSPECIFIED BREAST SURGERY WITH A 500CC ARTOURA BREAST TISSUE EXPANDER AND WAS PRESENTED WITH UNKNOWN SIDE DEFLATION. AS A RESULT, THE EXPANDER WAS EXPLANTED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8995724 ↗
• InjurySep 11, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH AN ARTOURA BREAST TISSUE EXPANDER 500CC AND EXPERIENCED DEFLATION OF THE RIGHT TISSUE EXPANDER. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7866734 ↗
• InjuryAug 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, ARTOURA BREAST TISSUE EXPANDER 500CC WAS RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB WITH NO ACCOMPANYING INFORMATION. THE DEVICE WAS PROCESSED ON (B)(6) 2018. 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, IT WILL BE CONSERVATIVELY REPORTED TO FDA AS AN EVENT REQUIRING MEDICAL DEVICE REMOVAL FROM A PATIENT.

  Patient problems: No Code Available

  MAUDE report 7759690 ↗
• MalfunctionJul 25, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A 500CC ARTOURA BREAST TISSUE EXPANDER WOULD NOT FILL UP OR WITHDRAWAL PROPERLY. THIS WAS NOTED PRIOR TO INSERTION, AND THE PRODUCT NEVER CONTACTED THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7719576 ↗