ARTOURA Breast Tissue Expander SMXP130RUHRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00081317024392), received between Feb 20, 2019 and May 26, 2022 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED SURGERY WITH A MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE 650CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. IT WAS REPORTED THAT THE RIGHT BREAST TISSUE EXPANDER WOULD NOT FILL CORRECTLY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14518027 ↗
• InjuryMar 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) BLACK FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF AN UNDISCLOSED BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT TISSUE EXPANDER AFTER AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 560CC MENTOR MEMORYGEL BREAST IMPLANT ON (B)(6), 2022. AFTER REMOVAL THE SURGEON NOTED A TEAR WHERE THE BUFFER ZONE IS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13932472 ↗
• InjuryDec 14, 2021Off-Label Use; Material Rupture; Use of Device Problem; Improper or Incorrect Procedure or Method; Off-Label Use; Material Rupture; Use of Device Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH AN ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021. THE TISSUE EXPANDER WAS IN USE FOR MORE THAN SIX MONTHS, WHICH IS CONSIDERED OFF LABEL USE OF THE PRODUCT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13005575 ↗
• InjuryOct 27, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 650CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA AN OFFICE EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12704691 ↗
• MalfunctionSep 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE WHO WAS GOING TO HAVE AN UNKNOWN PROCEDURE WITH AN ARTOURA BREAST, 650CC, TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION PRE-IMPLANTATION. THE HEALTH CARE PROFESSIONAL RECEIVED AN EXPANDER WITH A HOLE IN IT. NO ADVERSE EVENT OR PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507637 ↗
• InjuryMay 14, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION SURGERY WITH A 650CC ARTOURA BREAST TISSUE EXPANDER, AND EXPERIENCED LEFT SIDE EXPANDER DEFLATION POSTOPERATIVELY. AS A RESULT, THE EXPANDER WAS EXPLANTED ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11825764 ↗
• InjuryFeb 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH AN ARTOURA BREAST TISSUE EXPANDER 650CC. DURING EXPLANTATION ON (B)(6) 2021, THE DEVICE WAS FOUND TO BE DEFLATED. THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR TISSUE EXPANDERS (SERIAL NUMBERS (B)(4)).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11366420 ↗
• InjuryJun 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 650CC ARTOURA BREAST TISSUE EXPANDER (LEFT) AND AN UNSPECIFIED TISSUE EXPANDER (RIGHT) EXPERIENCED LEFT-SIDED DEFLATION AND RIGHT-SIDED SEROMA POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH A 535CC MENTOR MEMORYGEL BREAST IMPLANT (LEFT CATALOG #: SHPX535, LEFT SERIAL #: (B)(4)) AND A 490CC MENTOR MEMORYGEL BREAST IMPLANT (RIGHT CATALOG #: SHPX490, RIGHT SERIAL #: (B)(4)) ON (B)(6) 2020. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 10120759 ↗
• InjuryMay 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH 650CC MENTOR ARTOURA BREAST TISSUE EXPANDERS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10045686 ↗
• InjuryApr 1, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH A 650CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED DEFLATION ON AN UNKNOWN ON SIDE POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9913380 ↗
• InjuryAug 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH ARTOURA BREAST TISSUE EXPANDER 650CC AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST -OPERATIVELY. AS A RESULT, THE PATIENT WOULD UNDERGO EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8885049 ↗
• InjuryFeb 20, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 650CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED LEFT SIDED DEFLATION ON AN UNKNOWN DATE POST PROCEDURE. AS A RESULT, THE EXPLANT AND REPLACEMENT WITH ANOTHER 650CC ARTOURA BREAST TISSUE EXPANDER WAS PERFORMED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8355047 ↗

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-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
• 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,