MENTOR ARTOURA PLUS, Smooth, High Profile SDC130HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10081317028243), received between May 10, 2021 and Jun 17, 2025 — classified as 8 injuries, 3 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.

• InjuryJun 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE 475CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST TISSUE EXPANDER WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL ENHANCE BREAST IMPLANT 930CC GEL BREAST PROSTHESES ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22217092 ↗
• MalfunctionMay 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 475CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER WAS OBSERVED TO LEAK FLUID FROM THE BULB DURING A BREAST SURGERY PRIOR TO BEING IMPLANTED INTO THE PATIENT. THE SURGERY WAS COMPLETED; HOWEVER, THE MALFUNCTION CAUSED A 10 MINUTE SURGICAL DELAY. NO ADVERSE EVENTS OR PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288060 ↗
• InjuryApr 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH AN UNSPECIFIED MENTOR SALINE BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT EXPERIENCED A DEFLATION OF HER LEFT PROSTHESIS, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19110227 ↗
• MalfunctionMar 13, 2024

  ATTENDING MD (MEDICAL DOCTOR) TESTED IMPLANT FOR LEAKS BEFORE IMPLANTING EXPANDER AND NOTED THERE WAS A LEAK. IMPLANT WAS NOT USED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893157 ↗
• MalfunctionJan 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 475CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER WAS FOUND TO BE DEFLATED PRIOR TO AN OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581154 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 72-YEAR-OLD HISPANIC FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE, 475CC SALINE EXPANDER EXPERIENCED LEFT-SIDED: (NO INFORMATION AVAILABLE), POST PROCEDURE. AS A RESULT, PATIENT REPLACED THE DEVICE WITH L) REF # SDC130H SN (B)(4) ON (B)(6) 2023.

  Patient problems: Hematoma; Insufficient Information

  MAUDE report 16885276 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 72-YEAR-OLD HISPANIC FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE, 475CC SALINE EXPANDER EXPERIENCED LEFT-SIDED: (NO INFORMATION AVAILABLE), POST PROCEDURE. AS A RESULT, PATIENT REPLACED THE DEVICE WITH L) REF # (B)(4), SN (B)(6) ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 16876924 ↗
• InjuryMay 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION SURGERY WITH IMPLANT AND WAS PRESENTED WITH 475CC ARTOURA PLUS SMOOTH HIGH PROFILE AND EXPERIENCED RIGHT SIDE DEFLATION. THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH CATALOG NUMBER SMPB545, (B)(4) ON THE LEFT SIDE, AND WITH CATALOG NUMBER SMPB545, (B)(4) ON THE RIGHT SIDE ON AN UNKNOWN DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14395754 ↗
• InjuryApr 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WITH AN ARTOURA PLUS SMOOTH HIGH PROFILE 475CC AND EXPERIENCED DEFLATION (SIDE UNKNOWN) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2021. THE DEVICE SERIAL NUMBER WAS REPORTED AS (B)(4); HOWEVER, THIS SERIAL NUMBER IS NOT ASSOCIATED WITH ANY CURRENT MENTOR PRODUCTS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14227395 ↗
• InjuryOct 15, 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 HISPANIC FEMALE PATIENT UNDERWENT A MASTECTOMY WITH AN ARTOURA PLUS SMOOTH HIGH PROFILE 475CC AND EXPERIENCED AN INFECTION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2021.

  Patient problems: Post Operative Wound Infection

  MAUDE report 12641319 ↗
• InjuryMay 10, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD AFRICAN AMERICAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 475CC ARTOURA PLUS SMOOTH HIGH PROFILE TISSUE EXPANDER EXPERIENCED DEFLATION AND SEROMA POST PROCEDURE. ON AN UNSPECIFIED DATE, PATIENT¿S CAT JUMPED ON HER CHEST CAUSING THE DEFLATION. AS A RESULT, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A LIKE DEVICE ON (B)(6) 2021

  Patient problems: Fall; Hematoma

  MAUDE report 11803376 ↗

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