MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC130UHRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10081317028229), received between Jun 14, 2022 and Sep 5, 2025 — classified as 17 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (18 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE TISSUE EXPANDERS EXPERIENCED BILATERAL DEFLATION POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22982817 ↗
• InjurySep 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE TISSUE EXPANDERS EXPERIENCED BILATERAL DEFLATION POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22982345 ↗
• MalfunctionAug 21, 2025Material Discolored; Device Contamination with Chemical or Other Material; Material Discolored; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE 650CC TISSUE EXPANDER APPEARED CLOUDY AND FOGGY AND A FLUID WAS INSIDE THE DEVICE. THE SURGEON DID NOT WANT TO USE THE DEVICE IN A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865011 ↗
• InjuryJul 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 650CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE TISSUE EXPANDER EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22531346 ↗
• InjuryApr 28, 2025Material Rupture; Use of Device Problem; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 650CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21920433 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION USING A MENTOR ARTOURA PLUS SMOOTH ULTRA HIGH PROFILE 650CC SALINE TISSUE EXPANDER ON THE LEFT AND AN UNKNOWN MENTOR SILICONE PROSTHESIS ON THE RIGHT EXPERIENCED BILATERAL IMPAIRED HEALING AND A HEMATOMA AT THE LEFT IMPLANT SITE POSTOPERATIVELY. THE DELAYED HEMATOMA ON THE LEFT SIDE NECESSITATED A SURGICAL EVACUATION. FOLLOWING THIS COMPLICATION, THE PATIENT EXHIBITED CONTINUED IMPAIRED HEALING BILATERALLY, PROMPTING A DECISION TO ATTEMPT IMPLANT SALVAGE THROUGH BILATERAL REPLACEMENT WITH A VANCOMYCIN AND GENTAMICIN SLURRY. SUBSEQUENTLY, THE PATIENT UNDERWENT LEFT-SIDED REPLACEMENT WITH A MENTOR SMHX470 IMPLANT (SN (B)(6)) ON (B)(6) 2025, TO ADDRESS THE COMPLICATIONS AND OPTIMIZE HEALING. THIS REPRT RELATES TO THE LEFT SIDE.

  Patient problems: Hematoma; Impaired Healing

  MAUDE report 21874365 ↗
• InjuryMar 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH-PROFILE TISSUE EXPANDER AND EXPERIENCED BREAST PAIN AND DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA CT SCAN. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2025.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 21684428 ↗
• InjuryJun 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 650CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST TISSUE EXPANDER BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19515807 ↗
• InjuryApr 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH IMPLANTATION OF A 650CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT OBSERVED HER RIGHT BREAST WAS DEFLATED AFTER SHOWERING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH 480CC MENTOR MEMORYGEL BOOST BREAST IMPLANTS ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19145815 ↗
• InjuryApr 3, 2024Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH A 650CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE AND EXPERIENCED ANOTHER SPONTANEOUS DEFLATION TO HER REPLACEMENT TISSUE EXPANDER AND NEEDED ANOTHER SURGERY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19033777 ↗
• InjuryFeb 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE 650CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST TISSUE EXPANDER WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE 650CC TISSUE EXPANDER ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18656016 ↗
• InjuryJan 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 50-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 650CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024, AND REPLACED WITH A MENTOR SALINE BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18592123 ↗
• MalfunctionJan 10, 2024Material Rupture; Defective Device; Material Rupture; Defective Device

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE, 650CC SALINE TISSUE EXPANDER EXPERIENCED UNKNOWN SIDED DEFECTIVE DEVICE BEFORE OPERATING. THE REPORT INDICATES THE FOLLOWING: WE OPENED A TISSUE EXPANDER FROM OUR CONSIGNMENT AND DURING THE CASE REALIZED IT WAS DEFECTIVE. IT DID CONTACT PATIENT, AND WE HAD THE EXPANDER STERILIZED. NO PATIENT CONSEQUENCES OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18488887 ↗
• InjuryJan 9, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH A 650CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE AND EXPERIENCED RIGHT SIDE EXPANDER DEFLATION. AS A RESULT, THE PATIENT UNDERWENT RIGHT SIDE REPLACEMENT SURGERY WITH CATALOG NUMBER SDC130UH; SERIAL NUMBER (B)(6) ON (B)(6), 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18476392 ↗
• InjuryDec 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE, SALINE PROSTHESIS EXPERIENCED RIGHT-SIDE DEFLATION POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT REPLACEMENT WITH REF: SDC-130UH, SN: ((B)(6), 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18383252 ↗
• InjuryJun 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 46-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 650CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE 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 17080499 ↗
• InjuryJun 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF AN UNDISCLOSED MENTOR BREAST TISSUE EXPANDER PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A RUPTURED RIGHT BREAST EXPANDER BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN UNDISCLOSED PROSTHESIS ON (B)(6) 2023. THE DATE OF IMPLANTATION AND EVENT WERE NOT PROVIDED TO MENTOR. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17071412 ↗
• MalfunctionApr 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 650CC MENTOR ARTOURA PLUS SMOOTH ULTRA HIGH-PROFILE TISSUE EXPANDER WAS TORN OUT OF THE BOX. THE PROCEDURE WAS CONTINUED USING A BACKUP TISSUE EXPANDER WITHOUT PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724712 ↗
• InjuryApr 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 650CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE AND EXPERIENCED EXPANDER DEFLATION ON HER LEFT SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16700280 ↗
• InjuryJun 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE 650CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. IT WAS REPORTED THAT THERE WAS A TEAR IN THE SEAM OF THE DEVICE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14685592 ↗

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
• 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,