MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC140UHRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10081317028281), received between Apr 4, 2023 and Feb 20, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 850CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025 AND REPLACED WITH A MENTOR SALINE BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21423231 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 850CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH-PROFILE TISSUE EXPANDER AND EXPERIENCED AN INFECTION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20888858 ↗
• InjuryOct 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE TISSUE EXPANDERS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20398537 ↗
• InjurySep 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE 850CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. THE SURGEON NOTICED A DEFECT ON THE RIGHT BREAST¿S TISSUE EXPANDER. ADDITIONALLY, THE PATIENT DEVELOPED AN INFECTION IN HER RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement; Emotional Changes; Post Operative Wound Infection

  MAUDE report 17733136 ↗
• InjuryApr 5, 2023Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD 850CC MENTOR ARTOURA PLUS SMOOTH ULTRA HIGH-PROFILE TISSUE EXPANDERS PLACED EXPERIENCED BILATERAL DEVICE MIGRATION POST PROCEDURE. THE EXPANDERS FLIPPED BACKWARDS 180 DEGREES. THE DEVICES WERE ABLE TO BE FLIPPED BACK INTO PLACE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2023-04017 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16686803 ↗
• InjuryApr 5, 2023Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD 850CC MENTOR ARTOURA PLUS SMOOTH ULTRA HIGH-PROFILE TISSUE EXPANDERS PLACED EXPERIENCED BILATERAL DEVICE MIGRATION POST PROCEDURE. THE EXPANDERS FLIPPED BACKWARDS 180 DEGREES. THE DEVICES WERE ABLE TO BE FLIPPED BACK INTO PLACE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2023-04016 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16686798 ↗
• MalfunctionApr 4, 2023Break; Break

  IT WAS REPORTED THAT A 850CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE WAS DISCOVERED, PRE-IMPLANTATION, TO HAVE BEEN PACKAGED WITH BROKEN NON-MENTOR (B BRAUN) WINGED INFUSION SET. THE WINGED INFUSION'S TUBING WAS SEVERED IN HALF. PER MENTOR'S PROCEDURE'S, THIS IS NOT REPORTABLE BECAUSE THE MOST LIKELY CONSEQUENCE IS A INTRA-PROCEDURAL DELAY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. HOWEVER, PER PRODUCT INVESTIGATION'S RESULTS, MENTOR WILL REPORT THIS CONSERVATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675685 ↗

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,