MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC135UHRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10081317028236), received between Aug 2, 2022 and Apr 20, 2026 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (12 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-1687-2026 · 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.

• MalfunctionApr 20, 2026Material Rupture

  IT WAS REPORTED THAT 700CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE BEING USED FOR A BREAST SURGERY RUPTURED INTRAOPERATIVELY DUE TO THE SEAM COMING APART. THERE WERE NO PATIENT CONSEQUENCES OR ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924270 ↗
• InjuryOct 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 700 CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE AND EXPERIENCED EXPANDER DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23278803 ↗
• InjuryMay 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH 700CC MENTOR ARTOURA PLUS SMOOTH ULTRA HIGH-PROFILE TISSUE EXPANDERS EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22074267 ↗
• InjuryMay 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH 700CC MENTOR ARTOURA PLUS SMOOTH ULTRA HIGH-PROFILE TISSUE EXPANDERS EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22074237 ↗
• InjuryApr 23, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST IMPLANTATION SURGERY WITH A 700CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH-PROFILE TISSUE EXPANDER ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21894099 ↗
• InjuryOct 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO HAD A 700CC MENTOR ARTOURA PLUS SMOOTH ULTRA HIGH-PROFILE TISSUE EXPANDER PLACED EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. REPLACEMENT WITH A PERMANENT IMPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20546831 ↗
• InjurySep 18, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 700CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH-PROFILE TISSUE EXPANDER EXPERIENCED AN UNSPECIFIED DEVICE ISSUE ON THE LEFT SIDE POST PROCEDURE. THE DEVICE WAS STATED TO HAVE FAILED. AS A RESULT, EXPLANT AND REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20249736 ↗
• InjuryJun 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE TISSUE EXPANDERS 700CC AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR GEL BREAST IMPLANTS ON (B)(6), 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19485195 ↗
• InjuryMay 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO HAD 700CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE TISSUE EXPANDERS EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. THERE WAS AN ABSENCE OF BREASTS AND NIPPLES NOTED. AS A RESULT, REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19384538 ↗
• InjuryMay 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO HAD 700CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE TISSUE EXPANDERS EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. THERE WAS AN ABSENCE OF BREASTS AND NIPPLES NOTED. AS A RESULT, REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19384511 ↗
• InjuryApr 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 700CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19028639 ↗
• MalfunctionMar 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 700CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH-PROFILE TISSUE EXPANDER BEING USED IN A BREAST SURGERY WAS FOUND TO BE DEFLATED DURING THE OPERATION. IT WAS STATED THAT THERE WAS A DEFECT AT THE JUNCTION OF THE BUFFER ZONE AND THE MAIN BODY. THE TISSUE EXPANDER DID NOT TOUCH THE PATIENT. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18926828 ↗
• InjuryMar 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 72-YEAR-OLD BLACK OR AFRICAN AMERICAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 700CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE AND EXPERIENCED EXPANDER DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT IS SCHEDULED FOR A REPLACEMENT SURGERY WITH SMOOTH ROUND HIGH PROFILE BREAST IMPLANTS ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16521993 ↗
• MalfunctionAug 2, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT DURING A BREAST RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE BACK PATCH WITH SUTURE TABS ON A MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE 700CC TISSUE EXPANDER HAD BEEN MANUFACTURED UPSIDE DOWN. THE DEVICE WAS IMPLANTED IN THE PATIENT¿S LEFT BREAST SINCE THE SURGEON DETERMINED IT WOULD NOT AFFECT THE SURGICAL OUTCOME. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15151020 ↗

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,