ARTOURA Breast Tissue Expander TEXP100RUHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00081317009528), received between Jan 23, 2020 and Feb 10, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Rupture” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH 350CC ARTOURA BREAST TISSUE EXPANDERS AND EXPERIENCED POSTOPERATIVE LEFT-SIDED DEFLATION. THE PATIENT REPORTED THAT THE DIAGNOSIS WAS CONFIRMED BY A PHYSICIAN UPON EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 9690942 ↗
• InjuryJan 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR BREAST TISSUE EXPANDER, ARTOURA UHP BREAST TE 350 CC, SALINE BREAST IMPLANTS WHICH THE RIGHT SIDE DEFLATED AFTER IMPLANTATION.REPORT INDICATED NOTICEABLE DECREASED VOLUME. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. AS A RESULT PATIENT UNDERWENT REMOVAL AND REPLACEMENT OF THE RIGHT EXPANDER WITH NEW MENTOR SN#: (B)(4), SN#: (B)(4) ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9621662 ↗