MENTOR ARTOURA PLUS, Smooth, High Profile SDC110HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10081317028175), received between Mar 21, 2023 and Dec 10, 2024 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A 300 CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER HAD A SPOT OF BLACK MATERIAL UPON OPENING. THE PHYSICIAN DID NOT FEEL COMFORTABLE USING THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898614 ↗
• InjuryOct 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 300CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE AND EXPERIENCED EXPANDER DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. PER THE INFORMATION PROVIDED, THE PATIENT HAS A HISTORY OF RIGHT BREAST CANCER, WHICH LED TO THE USE OF TISSUE EXPANDERS. THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH SERIAL NUMBERS (B)(6) ON THE LEFT SIDE, AND WITH (B)(6) ON THE RIGHT SIDE ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20404284 ↗
• InjuryAug 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 300CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19967076 ↗
• InjuryFeb 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH A 300CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER LEFT SIDE. FOLLOW-UP WILL BE PERFORMED TO UNDERSTAND WHEN THE ASPIRATION THAT LED TO DEFLATION WAS DONE. SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF INFORMATION. THE PATIENT UNDERWENT LEFT SIDE REPLACEMENT SURGERY WITH CATALOG NUMBER SMPB290; SERIAL NUMBER (B)(6) ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18748699 ↗
• MalfunctionOct 23, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS PLASTIC FOUND INSIDE THE 300CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE DURING BREAST SURGERY. HEALTHCARE PROFESSIONAL STATED THAT THERE WAS PATIENT CONTACT BUT THE DOCTOR REMOVED IT BEFORE IMPLANT WAS FULLY PLACED, AND PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17984408 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION PROCEDURE WITH 300CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE ON BOTH SIDES AND EXPERIENCED GENERALIZED SYMPTOMS INCLUDING FOOD ALLERGIES, ALPHA-GAL SYNDROME, HAIR LOSS, IRRITATION, AND NECROSIS/ POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER SMPB480; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6), 2023. NO IMPLANT WAS PLACED ON THE LEFT SIDE. IT WAS REPORTED THAT PATIENT'S SYMPTOMS DID NOT IMPROVE AFTER THE SURGERY. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17548259 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION PROCEDURE WITH 300CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE ON BOTH SIDES AND EXPERIENCED GENERALIZED SYMPTOMS INCLUDING FOOD ALLERGIES, ALPHA-GAL SYNDROME, HAIR LOSS, IRRITATION, AND NECROSIS/ POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER SMPB480; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2023. NO IMPLANT WAS PLACED ON THE LEFT SIDE. IT WAS REPORTED THAT PATIENT'S SYMPTOMS DID NOT IMPROVE AFTER THE SURGERY. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17548240 ↗
• InjuryMar 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH AN UNSPECIFIED MENTOR TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNKNOWN DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16585588 ↗

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