ARTOURA Breast Tissue Expander SMXP150RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00081317024347), received between Jun 14, 2018 and Oct 29, 2024 — classified as 40 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (40 reports).

2 other recalls cover devices cleared under the same FDA submission (K161176); they may or may not involve this specific model.

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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH ARTOURA BREAST TISSUE EXPANDER 750CC AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A MENTOR GEL BREAST IMPLANT ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20561377 ↗
• InjuryFeb 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR ARTOURA BREAST TISSUE EXPANDER 750CC AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13549663 ↗
• InjuryJan 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD AFRICAN AMERICAN FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST RECONSTRUCTION WITH TWO 750CC ARTOURA BREAST TISSUE EXPANDERS, SUFFERED SPONTANEOUS LEFT BREAST IMPLANT DEFLATION AND LEFT BREAST ASYMMETRY AND SEROMA, POST-PROCEDURE. THE COMPLICATIONS WERE DIAGNOSED DURING AN IN-OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 750CC ARTOURA BREAST TISSUE EXPANDER (CATALOG: SMXP150RH LOT: 9413923 SN: (B)(4) ON (B)(6) 2021.

  Patient problems: Seroma

  MAUDE report 13338059 ↗
• InjuryJan 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST RECONSTRUCTION WITH TWO 750CC ARTOURA BREAST TISSUE EXPANDERS, SUFFERED RIGHT BREAST IMPLANT DEFLATION, POST-PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED SILICONE IMPLANT ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13212452 ↗
• InjuryApr 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH 750CC ARTOURA BREAST TISSUE EXPANDERS EXPERIENCED BILATERAL EXPANDER DEFLATION POSTOPERATIVELY. DEFLATION WAS DIAGNOSED BY PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH 790CC MENTOR MEMORYGEL BREAST IMPLANTS, CATALOG # SHPX790, LEFT LOT-SERIAL # (B)(4) AND RIGHT LOT-SERIAL # (B)(4) ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE LEFT-SIDED IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11611944 ↗
• InjuryApr 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH 750CC ARTOURA BREAST TISSUE EXPANDERS EXPERIENCED BILATERAL EXPANDER DEFLATION POSTOPERATIVELY. DEFLATION WAS DIAGNOSED BY PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH 790CC MENTOR MEMORYGEL BREAST IMPLANTS, CATALOG # SHPX790, LEFT LOT-SERIAL # (B)(4) AND RIGHT LOT-SERIAL # (B)(4) ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11611943 ↗
• InjuryMar 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION SURGERY WITH A 750CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED BREAST IMPLANT ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11441021 ↗
• MalfunctionDec 10, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR ARTOURA BREAST TISSUE EXPANDER, 750CC, SALINE IMPLANT DEFLATED BEFORE THE SURGERY. THE REPORTER INDICATED THAT THIS EXPANDER WAS NEVER IN CONTACT WITH THE PATIENT. A SEPARATE STERILE FIELD IS SET UP FOR THE PLASTIC SURGEON. THE PLASTIC SURGEON DOES A TEST FILL PRIOR TO INSERTING THE EXPANDER. AT THAT TIME, HE NOTED THERE TO BE LEAKING FROM THE EXPANDER. HE HAD NOT PLACED IT IN OR ON THE PATIENT, AT ANY TIME. HE HAD NOT TOUCHED THE PATIENT YET AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10987670 ↗
• InjuryNov 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH 750CC SALINE MENTOR ARTOURA BREAST TISSUE EXPANDERS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10805899 ↗
• InjuryOct 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH AN ARTOURA BREAST TISSUE EXPANDER 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) 2020.

  Patient problems: No Code Available

  MAUDE report 10671464 ↗
• InjuryOct 12, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH AN ARTOURA BREAST TISSUE EXPANDER 750CC DEVICE THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT TISSUE EXPANDER WAS DIAGNOSED BY A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10667956 ↗
• InjuryAug 3, 2020Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT A FEMALE PATIENT OF AN UNKNOWN AGE, RACE, AND ETHNICITY UNDERWENT A UNSPECIFIED BREAST RECONSTRUCTION WITH 750CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED A DEFLATION AND A BROKEN SUTURE TAB ON HER RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION, AND REPLACEMENT WITH CATALOG NUMBER SMXP150RH; SERIAL NUMBER (B)(4) ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10359073 ↗
• InjuryJul 1, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 750 CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED EXPANDER DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER SMXP150RH AND LOT NUMBER 9379127 ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10218700 ↗
• InjuryJun 9, 2020Adverse 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 RECONSTRUCTION REVISION WITH A ARTOURA BREAST TISSUE EXPANDER 750CC ON THE LEFT SIDE AND WITH MENTOR SMOOTH ROUND MODERATE PROFILE 425CC ON THE RIGHT SIDE AND EXPERIENCED NEOPLASM MALIGNANT ON THE LEFT BREAST IMPLANT. THE RIGHT BREAST IMPLANT WAS REMOVED FOR AN UNKNOWN REASON. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 790CC ON THE LEFT SIDE AND WITH UNSPECIFIED MENTOR BREAST IMPLANT ON THE RIGHT SIDE (SERIAL NUMBER: (B)(4)) ON (B)(6) 2020. THIS MEDWATCH IS FOR THE LEFT SIDE.

  Patient problems: Cancer; No Code Available

  MAUDE report 10133925 ↗
• InjuryJun 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH ARTOURA BREAST TISSUE EXPANDER 750CC AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10131274 ↗
• InjuryApr 8, 2020Material Rupture; Defective Device; Material Rupture; Defective Device

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION SURGERY WITH A 750CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED RIGHT SIDED BREAST INFECTION, DEVICE EXTRUSION, DEFLATION, AND DEFECTIVE VALVE POST PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A NON-MENTOR BREAST IMPLANT ON (B)(6) 2019.

  Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 9935903 ↗
• InjuryApr 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH ARTOURA BREAST TISSUE EXPANDER 750CC 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) 2020.

  Patient problems: No Code Available

  MAUDE report 9929698 ↗
• InjuryMar 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH ARTOURA BREAST TISSUE EXPANDER 750CC AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9898470 ↗
• InjuryMar 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 750CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, REPLACEMENT WITH A NEW 750CC ARTOURA BREAST TISSUE EXPANDER WAS PERFORMED ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9842318 ↗
• InjuryFeb 19, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH AN ARTOURA BREAST TISSUE EXPANDER 750CC FILLED TO 400CC AND EXPERIENCED DEFLATION ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN ARTOURA BREAST TISSUE EXPANDER 750CC, CATALOG NUMBER SMXP150RH, SERIAL NUMBER (B)(4) ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9727896 ↗
• InjuryDec 20, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO HAD A 750CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, DEVICE REPLACEMENT WITH ANOTHER 750CC ARTOURA BREAST TISSUE EXPANDER WAS PERFORMED ON (B)(6) 2019. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME, IF ADDITIONAL DETAILS ARE MADE AVAILABLE IN THE FUTURE, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 9505791 ↗
• InjuryDec 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST RECONSTRUCTION SURGERY WITH MENTOR ARTOURA BREAST TISSUE EXPANDER, 750CC SALINE IMPLANTS WHICH THE UNKNOWN SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. AS A RESULT PATIENT HAD THE DEVICE EXPLANTED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9488358 ↗
• InjuryOct 29, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT BREAST SURGERY WITH AN ARTOURA BREAST TISSUE EXPANDER 750CC DEVICE THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT TISSUE EXPANDER WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A NON-MENTOR DEVICE ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9253859 ↗
• InjuryOct 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH 750CC ARTOURA BREAST TISSUE EXPANDER. IT WAS REPORTED THAT THE IINFERIOR MOST TAB TORE AND EXPANDER DEFLATED. 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 9239538 ↗
• InjuryAug 23, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT AN UNKNOWN PROCEDURE WITH A 750CC ARTOURA BREAST TISSUE EXPANDER SMOOTH HIGH PROFILE TISSUE EXPANDER EXPERIENCED LEFT SIDED RUPTURE POST PROCEDURE. THE LEFT SIDE RUPTURE WAS DIAGNOSED BY A PHYSICIAN. AS A RESULT, THE PATIENT HAD AN EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8928449 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161176. One submission often covers many models, so check the product and lot details in each record.

• Z-1686-2026 · Feb 18, 2026 · Open, Classified
  Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc,
• Z-1687-2026 · Feb 18, 2026 · Open, Classified
  Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc