ARTOURA Breast Tissue Expander TEXP140RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00081317009498), received between Mar 29, 2018 and Jul 30, 2026 — classified as 17 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (13 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent breast reconstruction with two 600cc ARTOURA Breast Tissue Expanders. Post-operatively, the patient suffered bilateral breast infection. As a result, the patient underwent breast implant removal and replacement surgery on (b)(6)2026. The replacement devices were two Mentor gel implants.This Medwatch form is for the right breast prosthesis.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50078092 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent breast reconstruction with two 600cc ARTOURA Breast Tissue Expanders. Post-operatively, the patient suffered bilateral breast infection. As a result, the patient underwent breast implant removal and replacement surgery on (b)(6) 2026. The replacement devices were two Mentor gel implants.This Medwatch form is for the left breast prosthesis.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50078090 ↗
• InjuryJun 2, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 600CC ARTOURA BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED EXPANDER OF AN UNDISCLOSED SIDE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT EXPANDER REMOVAL ON (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 25365980 ↗
• InjuryAug 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION SURGERY WITH UNKNOWN SIZE UNKNOWN TISSUE EXPANDERS AND EXPERIENCED UNKNOWN SIDE BREAST IMPLANT DEFLATION. AS A RESULT, THE EXPANDER WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17585124 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA MW5110140 THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WITH ARTOURA BREAST TISSUE EXPANDERS 600CC AND EXPERIENCED BILATERAL INFECTIONS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022. THIS REPORT IS FOR THE FIRST OF TWO DEVICES.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15015103 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA MW5110140 THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WITH ARTOURA BREAST TISSUE EXPANDERS 600CC AND EXPERIENCED BILATERAL INFECTIONS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022. THIS REPORT IS FOR THE SECOND OF TWO DEVICES.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15015079 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 600CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED A WOUND INFECTION ON AN UNSPECIFIED SIDE POST-OPERATIVELY. IT WAS INDICATED THE PATIENT REQUIRED SURGICAL INTERVENTION TO TREAT. THE PATIENT WAS REPORTED TO HAVE HAD THE DEVICE EXPLANTED, BUT AN EXPLICIT DATE OF EXPLANT WAS NOT PROVIDED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 14499109 ↗
• InjuryMay 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION SURGERY WITH A 600CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER TEXP140RH; SERIAL NUMBER: (B)(4) ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14338008 ↗
• MalfunctionOct 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT AN ARTOURA BREAST TISSUE EXPANDER 600CC DEVICE DEFLATED DURING A SCHEDULED BREAST RECONSTRUCTION PROCEDURE. IT WAS REPORTED THAT WHEN THE SURGEON TRIED TO FILL THE DEVICE WITH SALINE, THE DEVICE WOULD NOT HOLD THE SALINE. THE DEVICE WAS REMOVED AND A HOLE WAS DISCOVERED ON THE BACK SIDE OF IT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12693953 ↗
• InjuryOct 14, 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 FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 600CC ARTOURA BREAST TISSUE EXPANDER (LEFT) AND AN UNSPECIFIED MENTOR TISSUE EXPANDER (RIGHT) AND EXPERIENCED BILATERAL INFECTIONS POST-OPERATIVELY. THE RIGHT SIDE WAS TREATED WITH MEDICATION. THE LEFT SIDE WAS EXPLANTED ON (B)(6) 2021. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 12636717 ↗
• InjuryJun 25, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A 600CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. DURING A SERIES OF 180CC INJECTIONS AN ISSUE WITH THE EXPANDER WAS SUSPECTED. UPON REMOVAL, A LEAK WAS NOTED. AS A RESULT, THE DEVICE WAS REPLACED WITH A 425CC MENTOR MEMORYGEL BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 10197230 ↗
• InjuryDec 22, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION SURGERY WITH A 600CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED DEFLATION (SIDE UNKNOWN) POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9508836 ↗
• InjuryFeb 22, 2019Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR ARTOURA BREAST TISSUE EXPANDER 600CC ON (B)(6) 2017 EXPERIENCED RIGHT SIDE EXPANDER DEFLATION THAT WAS OBSERVED ON (B)(6) 2018. THE PATIENT UNDERWENT EXPLANTATION WITHOUT REPLACEMENT ON (B)(6) 2018. PER MENTOR IFU, TISSUE EXPANDERS ARE NOT INTENDED FOR IMPLANTATION BEYOND 6 MONTHS. THEREFORE, THIS DEVICE WAS USED IN AN OFF LABEL MANNER.

  Patient problems: No Code Available

  MAUDE report 8363100 ↗
• InjuryFeb 20, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE UNDERWENT RECONSTRUCTIVE BREAST SURGERY WITH A 600CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8356248 ↗
• InjuryJul 25, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH ARTOURA BREAST TISSUE EXPANDER 600CC BREAST PROSTHESIS. DEFLATION OF THE LEFT EXPANDER WAS IDENTIFIED. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 600CC GEL BREAST PROSTHESIS ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7721067 ↗
• MalfunctionJun 11, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION WITH A ARTOURA BREAST TISSUE EXPANDER 600CC. WHILE IMPLANTING THEN INFLATING, THE PHYSICIAN NOTED THE TISSUE EXPANDER WAS LEAKING. AS A RESULT, THE TISSUE EXPANDER WAS REPLACED INTRA-OPERATIVELY WITH AN ARTOURA BREAST TISSUE EXPANDER 600CC. NO PATIENT CONSEQUENCE NOR PROCEDURAL DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7589197 ↗
• InjuryMay 1, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A ARTOURA BREAST TISSUE EXPANDER 600CC. DEFLATION ON THE LEFT BREAST TISSUE EXPANDER WAS DIAGNOSED POST PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A ARTOURA BREAST TISSUE EXPANDER 600CC ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7478510 ↗
• InjuryApr 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR OLD FEMALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH ARTOURA BREAST TISSUE EXPANDER 600CC DEVICES. DEFLATION ON THE LEFT DEVICE WAS DETERMINED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH ARTOURA BREAST TISSUE EXPANDER 600CC DEVICE ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7449215 ↗
• InjuryMar 29, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH ARTOURA BREAST TISSUE EXPANDER 600CC DEVICES. LEAK ON THE LEFT DEVICE WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7381557 ↗