ARTOURA Breast Tissue Expander SMXP130RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00081317024316), received between Apr 12, 2018 and Jun 10, 2022 — classified as 15 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (14 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH A 475 ARTOURA BREAST TISSUE EXPANDER EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14660351 ↗
• InjuryAug 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WITH AN ARTOURA BREAST TISSUE EXPANDER 475CC 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 TISSUE EXPANDER (SERIAL NUMBER (B)(4)) ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12288756 ↗
• InjuryFeb 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A ARTOURA BREAST TISSUE EXPANDER 475CC AND SUFFERED FROM DEFLATION ON THE LEFT SIDE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH EXTRA HP IMPLANTS ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11388032 ↗
• InjuryJan 13, 2021Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH ARTOURA BREAST TISSUE EXPANDER 475CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED PROCEDURE DELAY INTRAOPERATIVELY. THE REPORT INDICATED THAT THE SURGEON HAD TO OPERATE AND REPLACE AN EXPANDER. THE SURGEON ATTEMPTED TO FILL THE EXPANDER AND THE BUTTERFLY WHEN THROUGH THE BUFFER ZONE AND NOT THE PORT AND THE EXPANDER DEFLATED. THE SURGEON DID NOT SAVE THE EXPLANTED EXPANDER BUT HAD TO REPLACE IT, AND THIS DELAYED THE PROCEDURE BY 30 MINUTES. THE PROCEDURE COMPLETED BY USING A NEW MENTOR ARTOURA SMOOTH HP 475CC EXPANDER. NO SIGNS OR PATIENT SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167392 ↗
• MalfunctionSep 29, 2020No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2020, A 475CC ARTOURA BREAST TISSUE EXPANDER THAT WAS RETURNED TO MENTOR FOR ANALYSIS WAS FOUND TO BE DEFLATED. THE REASON FOR EXPLANT WAS NOT PROVIDED, BUT WITH THE INFORMATION AVAILABLE, IT WAS DETERMINED THAT THE DEVICE WAS EXPLANTED AS PART OF A STAGED RECONSTRUCTION. A 375CC MENTOR MEMORYGEL DEVICE WAS IMPLANTED IN ITS PLACE (CATALOG # 3503751BC, S/N (B)(4)). THERE WERE NO REPORTS OF ANY DEVICE ISSUE OR PATIENT CONSEQUENCE, AND MULTIPLE FOLLOW-UP ATTEMPTS WERE MADE WITHOUT RECEIVING A RESPONSE. MENTOR WILL REPORT THIS EVENT BASED ON THE ANALYSIS FINDINGS, AND IF ANY ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 10600824 ↗
• MalfunctionSep 29, 2020No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2020, A 475CC ARTOURA BREAST TISSUE EXPANDER THAT WAS RETURNED TO MENTOR FOR ANALYSIS WAS FOUND TO BE DEFLATED. THE REASON FOR EXPLANT WAS NOT PROVIDED, BUT WITH THE INFORMATION AVAILABLE, IT WAS DETERMINED THAT THE DEVICE WAS EXPLANTED AS PART OF A STAGED RECONSTRUCTION. A 375CC MENTOR MEMORYGEL DEVICE WAS IMPLANTED IN ITS PLACE (CATALOG #: 3503751BC, S/N (B)(4)). THERE WERE NO REPORTS OF ANY DEVICE ISSUE OR PATIENT CONSEQUENCE, AND MULTIPLE FOLLOW-UP ATTEMPTS WERE MADE WITHOUT RECEIVING A RESPONSE. MENTOR WILL REPORT THIS EVENT BASED ON THE ANALYSIS FINDINGS, AND IF ANY ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 10600822 ↗
• MalfunctionSep 25, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 475CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED DEFLATION ON AN UNSPECIFIED SIDE INTRA OPERATIVELY. PER PHYSICIAN, WHEN TRYING TO FILL EXPANDER IT DID NOT HOLD ANY FLUID. NO PROCEDURAL DELAYS OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10588696 ↗
• InjuryApr 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR ARTOURA BREAST TISSUE EXPANDER, 475CC SALINE BREAST IMPLANTS WHICH BILATERALLY DEFLATED AFTER IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT SIDE.

  Patient problems: No Code Available

  MAUDE report 9954288 ↗
• InjuryApr 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR ARTOURA BREAST TISSUE EXPANDER, 475CC SALINE BREAST IMPLANTS WHICH BILATERALLY DEFLATED AFTER IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT SIDE.

  Patient problems: No Code Available

  MAUDE report 9954238 ↗
• InjuryMar 17, 2020Defective Device; Defective Device

  ON (B)(6) 2020, A 475CC ARTOURA BREAST TISSUE EXPANDER WAS RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB. THE DEVICES 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 PER PAPERWORK RECEIVED WITH AN EXPLANT DATE OF (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9845807 ↗
• InjuryJan 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH AN ARTOURA BREAST TISSUE EXPANDER 475CC DEVICE THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST TISSUE EXPANDER WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 405CC GEL BREAST PROSTHESIS ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9541434 ↗
• InjuryNov 25, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH ARTOURA BREAST TISSUE EXPANDER 475CC AND EXPERIENCED UNSPECIFIED COMPLICATIONS RESULTING IN REMOVAL. THE PATIENT ALLEGED THEY HAD A DEFECTIVE DEVICE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9372773 ↗
• InjuryNov 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH AN ARTOURA BREAST TISSUE EXPANDER 475CC AND EXPERIENCED DEFLATION ON THE RIGHT BREAST TISSUE EXPANDER. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH UNSPECIFIED IMPLANT ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9271660 ↗
• InjuryOct 2, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD BLACK FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 475CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED POSTOPERATIVE UNILATERAL DEFLATION. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 475CC ARTOURA BREAST TISSUE EXPANDER, (CATALOG #: SMXP130RH, LOT #: 7692860-019) ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9146958 ↗
• InjuryNov 16, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY RECONSTRUCTION SURGERY WITH A ARTOURA BREAST TISSUE EXPANDER 475CC DEVICE THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE LEFT TISSUE EXPANDER DEVICE WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8081413 ↗
• MalfunctionAug 20, 2018Component Missing; Manufacturing, Packaging or Shipping Problem; Component Missing; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT WAS UNDERGOING AN UNKNOWN PROCEDURE WITH A MENTOR ARTOURA BREAST TISSUE EXPANDER 475CC TISSUE EXPANDER WHEN IT WAS NOTICED THAT THE NEEDLE INSIDE THE BOX WAS NOT THE CORRECT 21 GAUGE BUTTERFLY. THE NEEDLE INSIDE THAT BOX WAS AN 18 GAUGE WITH A GUIDE-WIRE. THE CORRECT NEEDLE WAS OBTAINED FROM THE BOX OF A DIFFERENT TISSUE EXPANDER (MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS TISSUE EXPANDER, CATALOG #3549213, SERIAL #(B)(4)) AND THE ARTOURA BREAST TISSUE EXPANDER 475CC TISSUE EXPANDER WAS PLACED IN THE PATIENT. THERE WAS NO CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7800053 ↗
• InjuryJul 25, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST PROCEDURE WITH MENTOR ARTOURA BREAST TISSUE EXPANDER, 475CC DEVICE WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. AS A RESULT PATIENT HAD THE DEVICE EXPLANTED AND REPLACED WITH A CATALOG NUMBER SMXP130RH ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7720581 ↗
• InjuryJun 8, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH ARTOURA BREAST TISSUE EXPANDER 475CC BREAST PROSTHESIS. DEFLATION OF THE RIGHT EXPANDER WAS VISUALLY DETERMINED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH ARTOURA BREAST TISSUE EXPANDER 475CC BREAST PROSTHESIS ON (B)(6) 2018. THE PATIENT EXPERIENCED NO ACCOMPANYING SYMPTOMS.

  Patient problems: No Code Available

  MAUDE report 7584734 ↗
• InjuryApr 12, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH ARTOURA 475CC TISSUE EXPANDER THAT THE LEFT SHOWED SMOOTH DEFLATION AFTER IMPLANTATION. SHELL APPEARED TO BE TORN BEHIND MIDDLE MOST INFERIOR TAB. THE LEFT IMPLANT SYMPTOMS WERE AXILLARY SWELLING, PERSISTENT SEROMA, PROLONG TIME NEEDING JP DRAIN. ON (B)(6) 2018, THE DEFLATED EXPANDER WAS REPLACED WITH A TEXTURED AROTURA, CATALOG NUMBER TEXP130RH. THE REPLACEMENT WAS DONE AS OUTPATIENT WITH NO HOSPITALIZATION.

  Patient problems: Inflammation; No Code Available; Seroma

  MAUDE report 7424562 ↗

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