ARTOURA Breast Tissue Expander SMXP120RUHRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00081317024385), received between Nov 19, 2018 and Nov 28, 2022 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH UNSPECIFIED MENTOR TISSUE EXPANDERS AND EXPERIENCED DEFLATION (SIDE UNKNOWN) POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15870785 ↗
• InjuryJun 4, 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 BREAST RECONSTRUCTION SURGERY WITH A 535CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED LEFT SIDED INFECTION POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2019.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11943572 ↗
• InjuryNov 3, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT, WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 535CC ARTOURA BREAST TISSUE EXPANDER ON THE LEFT SIDE, SUFFERED SPONTANEOUS LEFT BREAST IMPLANT DEFLATION, POST-PROCEDURE. THE DEFLATION WAS DIAGNOSED VIA PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT ON (B)(6) 2020 WITH A 535CC ARTOURA BREAST TISSUE EXPANDER (CATALOG: SMXP120RUH LOT: 7748085 SN: (B)(4)).

  Patient problems: No Code Available

  MAUDE report 10782289 ↗
• MalfunctionOct 3, 2020Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event

  ON (B)(6) 2020, A 535CC 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. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Not Applicable

  MAUDE report 10624122 ↗
• InjuryOct 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION SURGERY WITH A 535CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED DEFLATION ON AN UNKNOWN SIDE POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REMOVAL WITH NO REPLACEMENT ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10624074 ↗
• InjuryAug 27, 2020Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH ARTOURA BREAST TISSUE EXPANDER 535 CC 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. THE DEVICE WAS IMPLANTED FOR GREATER THAN SIX MONTHS, WHICH IS CONSIDERED OFF-LABEL USE OF THE DEVICE.

  Patient problems: No Code Available

  MAUDE report 10461102 ↗
• InjuryApr 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD HISPANIC FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH TWO 535CC ARTOURA BREAST TISSUE EXPANDERS, INITIALLY SUFFERED LEFT BREAST IMPLANT DISPLACEMENT WHEN SUTURES DISSOLVED OR CAME LOOSE ON (B)(6) 2019, WHICH WAS REPAIRED AND RE-SUTURED. THE PATIENT ALSO THEN DEVELOPED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT ON (B)(6) 2019 WITH THE FOLLOWING DEVICES: (LEFT) 490CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: SHPX490 LOT: 7676022 SN: (B)(4) AND (RIGHT) 535CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: SHPX560 LOT: 7709731 SN: (B)(4). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9931520 ↗
• InjuryApr 6, 2020Off-Label Use; Migration; Off-Label Use; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR OLD HISPANIC FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH TWO 535CC ARTOURA BREAST TISSUE EXPANDERS, INITIALLY SUFFERED LEFT BREAST IMPLANT DISPLACEMENT WHEN SUTURES DISSOLVED OR CAME LOOSE ON (B)(6) 2019, WHICH WAS REPAIRED AND RE-SUTURED. THE PATIENT ALSO THEN DEVELOPED BILATERAL CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT ON (B)(6) 2019 WITH THE FOLLOWING DEVICES: (LEFT) 490CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: SHPX490 LOT: 7676022 SN: (B)(4) AND (RIGHT) 535CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: SHPX560 LOT: 7709731 SN: (B)(4). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 9931519 ↗
• InjuryFeb 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH AN ARTOURA BREAST TISSUE EXPANDER 535CC 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 9721633 ↗
• InjuryJun 28, 2019Material Rupture; 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 535CC AND EXPERIENCED DEFLATION ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8744516 ↗
• MalfunctionNov 19, 2018Delivered as Unsterile Product; Device Damaged Prior to Receipt by User; Delivered as Unsterile Product; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT FOUR MENTOR TISSUE EXPANDER DEVICES (TWO ARTOURA BREAST TISSUE EXPANDER 500CC DEVICES, ONE ARTOURA BREAST TISSUE EXPANDER 535CC DEVICE, AND ONE ARTOURA BREAST TISSUE EXPANDER 700CC DEVICE) ARRIVED DAMAGED. THE OUTER SHIPPING BOX WAS SEVERELY DAMAGED AND APPEARED TO BE TAPED TOGETHER. THE DAMAGE TO THE DEVICE PACKAGING WAS NOT NOTICED UNTIL THE SHIPPING BOX WAS OPENED. DEVICE STERILITY WAS COMPROMISED. THE FOUR DEVICES WERE DESTROYED AND WERE NEVER USED IN A PATIENT. THERE WAS NO PATIENT CONTACT. THIS MEDWATCH REPORT IS FOR THE THIRD OF FOUR MENTOR ARTOURA BREAST TISSUE EXPANDER DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8087966 ↗

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,