MENTOR ARTOURA PLUS, Smooth, High Profile SDC120HRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10081317028199), received between Jan 4, 2022 and Jan 15, 2026 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 375CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE BREAST TISSUE EXPANDER. ON (B)(6) 2025, THE EXPANDER WAS REMOVED AND IT WAS NOTED THAT THE LEFT DEVICE WAS MISSING THE LOT NUMBER ENGRAVINGS. IT WAS DETERMINED THAT THE DEVICE HAD BEEN MISSING THE ENGRAVINGS AT THE TIME OF IMPLANTATION. THERE WERE NO ADVERSE EVENTS OR PATIENT HARMS/CONSEQUENCES DUE TO THE MISSING ENGRAVINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24089354 ↗
• InjuryMar 28, 2025Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  THE FEMALE PATIENT, WHO UNDERWENT BREAST RECONSTRUCTION WITH A MENTOR ARTOURA PLUS SMOOTH, HIGH-PROFILE 375CC SALINE PROSTHESIS, IS EXPERIENCING LEFT-SIDED DEFLATION OF THE EXPANDER, INDICATIVE OF A COMPROMISED INTEGRITY LIKELY DUE TO SEPARATION ISSUES. THE SITUATION WAS FIRST SUSPECTED AFTER THE PATIENT RECEIVED FOUR FILLS, AND DESPITE NO REPORTED TRAUMA, THE EXPANDER WENT FLAT SHORTLY AFTER FILLING. UPON EXAMINATION DURING ITS REMOVAL ON THE DESIGNATED DATE, A SEPARATION BETWEEN THE BASE WITH TABS AND THE BODY OF THE EXPANDER WAS CONFIRMED. CONSEQUENTLY, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2025, TO ADDRESS THIS COMPLICATION.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21726182 ↗
• InjuryJan 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 375CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER PROSTHESIS. POST-OPERATIVELY, THE PATIENT FELT A "BLOWOUT" AND OBSERVED THE RIGHT BREAST WAS FLAT. A CONSULTATION WITH A MEDICAL PROFESSIONAL WAS CONDUCTED AND SHE UNDERWENT UNILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT WITH A RIGHT-SIDED 375CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21087988 ↗
• InjuryAug 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 375CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, REPLACEMENT WITH MENTOR GEL BOOST WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19945103 ↗
• InjuryJan 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF AN UNDISCLOSED MENTOR TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS FOR AN UNDISCLOSED REASON. HOWEVER, DURING THE SURGERY A DEFLATED RIGHT BREAST IMPLANT WAS DISCOVERED. THERE WAS NO REPORTED PROCEDURAL DELAYS OR PATIENT CONSEQUENCES DUE TO THE DISCOVERY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18489382 ↗
• InjuryNov 2, 2023Material Rupture; Material Integrity Problem; Material Rupture; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR ARTOURA PLUS, SMOOTH HIGH PROFILE SALINE TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AND REPLACE THE DEVICE. UPON EXPLANTATION, IT WAS DISCOVERED THAT THE PATIENT¿S RIGHT PROSTHESIS HAD DEFLATED. THE SURGEON INDICATED THAT THE LEAK OCCURRED NEAR THE MAGNET SEAM. AS A RESULT, THE PATIENT¿S PROSTHESIS WAS REMOVED AND REPLACED WITH AN UNSPECIFIED MENTOR SILICONE BREAST IMPLANT ON (B)(6) 2023. THERE WERE NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED DUE TO THE DEFLATION DISCOVERED DURING THE REVISION SURGERY. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18056824 ↗
• MalfunctionJul 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 375CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER BEING USED IN A BREAST SURGERY WAS FOUND TO BE DEFLATED PRIOR TO THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY ANY PATIENT AND THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17409691 ↗
• MalfunctionNov 16, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT A 375CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER BEING USED IN A BREAST SURGERY WAS FOUND TO HAVE SHELL IRREGULARITIES DURING THE 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 15805907 ↗
• MalfunctionJan 4, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A 375CC ARTOURA PLUS SMOOTH HIGH PROFILE TISSUE EXPANDER WOULD NOT ASPERATE INTRA-OPERATIVELY. IT WAS REPORTED THAT AIR WAS LEAKING AS IF THERE WAS A HOLE IN THE EXPANDER. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13161222 ↗

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