ARTOURA Breast Tissue Expander TEXP110RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00081317009450), received between Jun 25, 2018 and Sep 1, 2020 — classified as 5 injuries.

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

• InjurySep 1, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 300CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020. UPON EXPLANTATION, THE DEFLATION WAS OBSERVED. AS THIS TIME OF REPORT, THE REASON FOR THE REVISION SURGERY IS UNKNOWN. MULTIPLE FOLLOW-UPS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 10479733 ↗
• InjuryDec 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A 300CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED POSTOPERATIVE BILATERAL DEFLATION, CONFIRMED BY A PHYSICIAN. THE PATIENT ULTIMATELY UNDERWENT EXPLANTATION AND PERMANENTLY IMPLANTED WITH 500CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANTS, CATALOG # 3503500, LEFT SERIAL # (B)(4) AND RIGHT SERIAL # (B)(4) ON (B)(6) 2019. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: No Code Available

  MAUDE report 9406445 ↗
• InjuryDec 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A 300CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED POSTOPERATIVE BILATERAL DEFLATION, CONFIRMED BY A PHYSICIAN. THE PATIENT ULTIMATELY UNDERWENT EXPLANTATION AND PERMANENTLY IMPLANTED WITH 500CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST IMPLANTS, CATALOG # 3503500, LEFT SERIAL # (B)(4) AND RIGHT SERIAL # (B)(4) ON (B)(6) 2019. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: No Code Available

  MAUDE report 9406418 ↗
• InjurySep 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH ARTOURA BREAST TISSUE EXPANDER 300CC AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8958141 ↗
• InjuryJun 25, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A ARTOURA BREAST TISSUE EXPANDER 300 CC. RUPTURE OF THE RIGHT BREAST TISSUE EXPANDER WAS REPORTED POST PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A MENTOR MEMORY SHAPE BREAST IMPLANT 685 CC GEL PROSTHESIS ON (B)(6) 2018.

  Patient problems: No Code Available; Pain

  MAUDE report 7635394 ↗