ARTOURA Breast Tissue Expander TEXP120RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00081317009467), received between Jun 11, 2018 and Mar 1, 2021 — classified as 11 injuries.

The most frequently reported specific device problem is “Material Rupture” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH AN ARTOURA BREAST TISSUE EXPANDER 375CC DEVICE SUFFERED FROM RIGHT BREAST PAIN AFTER IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN ARTOURA BREAST TISSUE EXPANDER 300CC DEVICE ON (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 11396726 ↗
• InjuryJan 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 375CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9537274 ↗
• InjuryDec 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 10/31/2019, ARTOURA BREAST TISSUE EXPANDER 375CC WAS RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB WITH NO ACCOMPANYING INFORMATION. THE DEVICE WAS FOR THE RIGHT SIDE. THE DEVICE WAS MARKED AS "DEFECTIVE," THOUGH NO SPECIFIC FAILURE MODE WAS NOTED. 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 9532407 ↗
• InjuryNov 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR ARTOURA BREAST TISSUE EXPANDER 375CC BREAST TISSUE EXPANDER WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. AS A RESULT PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT AS FOLLOW: LEFT REPLCED WITH CATALOG NUMBER SHPX415 SERIAL NUMBER (B)(4), AND RIGHT REPLACED WITH CATALOG NUMBER SHPX450, SERIAL NUMBER (B)(4) ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9341846 ↗
• InjuryAug 27, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST PROSTHESIS IMPLANTATION PROCEDURE WITH A 375CC ARTOURA BREAST TISSUE EXPANDER ON (B)(6) 2016, HAD TO GO UNDERGO EXPLANTATION JUST TEN MINUTES AFTER IMPLANTATION DUE TO THE DEVICE BEING DEFLATED. AS A RESULT, ANOTHER UNSPECIFIED DEVICE WAS IMPLANTED IN RETURN. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR ASR REFERENCE NUMBER (B)(4).

  Patient problems: No Code Available

  MAUDE report 8936697 ↗
• InjuryAug 16, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A SALINE MENTOR ARTOURA BREAST TISSUE EXPANDER 375CC AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIONAL. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8902076 ↗
• InjuryFeb 15, 2019Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH AN ARTOURA BREAST TISSUE EXPANDER 375CC. A HOLE WAS FOUND IN THE TISSUE EXPANDER DURING SURGERY AFTER IT WAS REMOVED DURING THE SECOND STAGE OF THE RECONSTRUCTION. THE TISSUE EXPANDER WAS REPLACED WITH MENTOR MEMORYGEL BREAST IMPLANTS 325CC, CATALOG NUMBER SMPX325, SERIAL NUMBER (B)(4), LOT NUMBER 7646576 (L) AND SERIAL NUMBER (B)(4), LOT NUMBER 7587582 (R) ON (B)(6) 2019. PER MENTOR IFU, THESE DEVICES ARE NOT INTENDED FOR USE BEYOND 6 MONTHS, AND THIS DEVICE WAS IMPLANTED FOR APPROXIMATELY 1 YEAR AND 4 MONTHS. THEREFORE THIS WAS AN OFF LABEL USE OF THE DEVICE.

  Patient problems: No Code Available

  MAUDE report 8343354 ↗
• InjuryDec 17, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH ARTOURA BREAST TISSUE EXPANDER 375CC AND EXPERIENCED DEFLATION ON THE RIGHT BREAST TISSUE EXPANDER. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH ARTOURA BREAST TISSUE EXPANDER 700CC ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8172138 ↗
• InjurySep 19, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST RECONSTRUCTIVE SURGERY WITH MENTOR ARTOURA BREAST TISSUE EXPANDER 375CC WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. AS A RESULT, PATIENT HAD THE DEVICE EXPLANTED ON 8/29/2018.

  Patient problems: No Code Available

  MAUDE report 7891626 ↗
• InjurySep 3, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A ARTOURA BREAST TISSUE EXPANDER 375CC AND EXPERIENCED DEFLATION ON THE LEFT TISSUE EXPANDER. THE PATIENT NOTICED THE DEFLATION. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH ON (B)(6) 2018. THE PATIENT HAD FULLY RECOVERED AFTER THE SURGERY. THE PATIENT WAS NOT HOSPITALIZED.

  Patient problems: No Code Available

  MAUDE report 7840951 ↗
• InjuryJun 11, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A ARTOURA BREAST TISSUE EXPANDER 375CC AND EXPERIENCED DEFLATION ON THE RIGHT TISSUE EXPANDER. THE DEFLATION WAS NOTICED BY THE DOCTOR AS THE DOCTOR OBSERVED THE SLOW LEAK IN THE TISSUE EXPANDER. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR GEL MEMORY SHAPE GEL DEVICE ON (B)(6) 2018. THERE WERE NO COMPLICATIONS AFTER THE SURGERY.

  Patient problems: No Code Available

  MAUDE report 7586848 ↗