MENTOR ARTOURA PLUS, Smooth, High Profile SDC140HRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10081317028267), received between May 25, 2021 and Feb 13, 2024 — classified as 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 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, 600CC SALINE, BREAST TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH NON-MENTOR IMPLANTS ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18697329 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD 600CC MENTOR ARTOURA PLUS SMOOTH HIGH PROFILE TISSUE EXPANDERS PLACED EXPERIENCED RIGHT SIDED DEFLATION AND LEFT SIDED MEDICAL DEVICE REMOVAL POST PROCEDURE. AS A RESULT, REPLACEMENT WITH UNKNOWN GEL WAS PERFORMED ON JUNE 20, 2023. THE RIGHT SIDED DEVICE WAS REPORTED INITIALLY UNDER 1645337-2023-08204. ON AUGUST 17, 2023 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF POSSIBLE BILATERAL ISSUES BASED ON THE CONDITION OF THE DEVICES RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 18193551 ↗
• InjuryOct 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 600CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17976942 ↗
• InjuryJul 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD A 600CC MENTOR ARTOURA PLUS SMOOTH HIGH PROFILE TISSUE EXPANDER PLACED EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, REPLACEMENT WITH UNKNOWN GEL WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17303274 ↗
• InjuryMay 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 600CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE AND EXPERIENCED LEFT SIDE DEFLATION POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16981677 ↗
• InjuryDec 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 51-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 600CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15973340 ↗
• InjuryOct 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH 600CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE SALINE TISSUE EXPANDERS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL DEFLATION, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNSPECIFIED NON-MENTOR BREAST IMPLANTS ON (B)(6) 2022. 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. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12762 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15659239 ↗
• InjuryOct 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH 600CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE SALINE TISSUE EXPANDERS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL DEFLATION, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNSPECIFIED NON-MENTOR BREAST IMPLANTS ON (B)(6) 2022. 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. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12763 FOR THE CONTRALATERAL EVENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15659236 ↗
• MalfunctionJul 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 600CC ARTOURA PLUS SMOOTH HIGH PROFILE TISSUE EXPANDER EXPERIENCED DEFLATION INTRA OPERATIVELY. NO ADVERSE EVENT AND NO PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15117696 ↗
• MalfunctionJul 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 600CC ARTOURA PLUS SMOOTH HIGH PROFILE TISSUE EXPANDER DEFLATION INTRA-OPERATIVELY. AS A RESULT, THE IMPLANT WAS REPLACED WITH AN UNSPECIFIED IMPLANT. THERE WAS NO REPORT OF ADVERSE EVENT OR PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14958959 ↗
• MalfunctionJun 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR ARTOURA PLUS SMOOTH HIGH PROFILE 600CC TISSUE EXPANDER RUPTURED INTRAOPERATIVELY. THERE WERE NO KNOWN PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14706976 ↗
• InjuryMay 19, 2022Filling Problem; Filling Problem

  IT WAS REPORTED THAT A MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE 600CC BEING USED IN AN UNSPECIFIED PROCEDURE WAS UNABLE TO BE INFLATED. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT, AND THERE WERE NO REPORTED SURGICAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14434359 ↗
• InjuryJan 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH A 600CC ARTOURA PLUS SMOOTH HIGH PROFILE TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REMOVAL WITH NO REPLACEMENT ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13388682 ↗
• MalfunctionMay 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH ARTOURA PLUS SMOOTH HIGH PROFILE 600CC TISSUE EXPANDER DEVELOPED DEFLATION INTRAOPERATIVELY. THE REPORT INDICATED THAT THE SURGEON PLACED EXPANDER AND STARTED TO FILL IT WITH SALINE. THE SALINE ENDED UP IN THE PICKET, THE SURGEON REMOVED EXPANDER AND PLACED A NEW ONE. THE PATIENT WAS PREPPED FOR SURGERY. NO ADVERSE EVENT OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11877280 ↗

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