MENTOR ARTOURA PLUS, Smooth, High Profile SDC150HRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10081317028274), received between Feb 10, 2022 and Jan 16, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

1. Feb 18, 2026Class IIOpen, Classified

   Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

   Z-1686-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 750CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE BREAST TISSUE EXPANDER PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT EXPANDER BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT RIGHT-SIDED EXCHANGE AND LEFT-SIDED IMPLANTATION WITH UNDISCLOSED BREAST TISSUE EXPANDERS ON (B)(6) 2025. POST-REVISION, THE SURGEON OBSERVED THE EXPLANTED DEVICE WAS COLLAPSED BUT COULD NOT FIND ANY TEARS OR LEAKS ON THE EXPANDER.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24099384 ↗
• InjurySep 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 750CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE SALINE BREAST PROSTHESIS ON AN UNSPECIFIED BREAST SIDE. POST-OPERATIVELY, THE PATIENT SUFFERED BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23028470 ↗
• InjuryMay 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE 750CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE 850CC TISSUE EXPANDER ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22064471 ↗
• InjuryJun 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION WITH TWO 750CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH POSSIBLE BREAST IMPLANT LEAKING. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19580997 ↗
• MalfunctionApr 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE, 770CC, TISSUE EXPANDER EXPERIENCED UNKNOWN-SIDED DEFLATION INTRAOPERATIVE. NO PATIENT INVOLVEMENT OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028538 ↗
• InjuryNov 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO UNSPECIFIED MENTOR TISSUE EXPANDERS EXPERIENCED BILATERAL DEFLATIONS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE RIGHT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18133573 ↗
• InjuryNov 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH TWO UNSPECIFIED MENTOR TISSUE EXPANDERS EXPERIENCED BILATERAL DEFLATIONS POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18133570 ↗
• InjuryAug 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 40-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE 750CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT TISSUE EXPANDER WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BOOST BREAST IMPLANT 520CC GEL BREAST PROSTHESIS ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17545853 ↗
• InjuryMay 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 750CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT EXPERIENCED A DEFLATION OF HER RIGHT PROSTHESIS, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16994394 ↗
• InjuryMay 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 750CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT TISSUE EXPANDER BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH AN UNDISCLOSED RIGHT-SIDED PROSTHESIS ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16860610 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 65-YEAR-OLD AFRICAN AMERICAN PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE 750CC TISSUE EXPANDER DEVELOPED AN INFECTION IN HER RIGHT BREAST POST IMPLANTATION. ERYTHEMA AND DRAINAGE OF THE RIGHT BREAST MOUND WERE OBSERVED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION WITH NO REPLACEMENT DEVICES ON (B)(6) 2023.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16469305 ↗
• InjuryMar 1, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 750CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16460842 ↗
• InjuryNov 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 750CC SMOOTH HIGH PROFILE MENTOR ARTOURA PLUS TISSUE EXPANDER EXPERIENCED DEFLATION ON AN UNKNOWN SIDE POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15854133 ↗
• InjuryFeb 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 750CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA AN OFFICE EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13507373 ↗

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