MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC120UHRecalls & reported problems
Mentor Texas L.P. · Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 535cc · Class U · Implant
All models of MENTOR ARTOURA PLUS, Smooth, Ultra High Profile (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10081317028212), received between Nov 18, 2021 and Nov 19, 2025 — classified as 14 injuries.
The most frequently reported specific device problem is “Material Rupture” (11 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Material Rupture11
- Adverse Event Without Identified Device or Use Problem2
- Connection Problem1
Patient problems
- Deformity/ Disfigurement12
- Hypersensitivity/Allergic reaction2
- Post Operative Wound Infection2
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 535CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE ON BOTH SIDES AND EXPERIENCED BILATERAL HYPERSENSITIVITY / ALLERGIC REACTION POSTOPERATIVELY. AS A RESULT, THE EXPANDERS WERE EXPLANTED ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 23594483 ↗InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 535CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE ON BOTH SIDES AND EXPERIENCED BILATERAL HYPERSENSITIVITY / ALLERGIC REACTION POSTOPERATIVELY. AS A RESULT, THE EXPANDERS WERE EXPLANTED ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 23594476 ↗InjuryAug 28, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 535CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH-PROFILE EXPANDER ON AN UNSPECIFIED BREAST SIDE, SUFFERED BREAST IMPLANT DEFLATION, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2025. THE REPLACEMENT WAS A MENTOR TISSUE EXPANDER.
Patient problems: Deformity/ Disfigurement
MAUDE report 22913819 ↗InjuryAug 8, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 535CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE BREAST TISSUE EXPANDER AND 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 22758472 ↗InjuryJun 18, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A MENTOR ARTOURA PLUS TISSUE EXPANDER EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED.
Patient problems: Deformity/ Disfigurement
MAUDE report 22286648 ↗InjuryAug 6, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH AN UNKNOWN TISSUE EXPANDER, SALINE PROSTHESIS EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVE. THE PATIENT REPORTED THAT NIGHT AFTER IT WAS LAST FILLED, THE RIGHT SIDE WAS TIGHT THEN RELEASED, FELT A POCKET OF FLUID BETWEEN THE BREAST AND EXPANDER. THE DOCTOR CONFIRMED THE FLUID WAS SALINE, AND TISSUE EXPANDER DEFLATED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 19924125 ↗InjuryJul 16, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 535CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH-PROFILE TISSUES EXPANDER EXPERIENCED A LEFT SIDED DEFECTIVE INJECTIVE PORT AND ANISOMASTIA POST PROCEDURE. THE ISSUE WAS NOTED DURING A SUBSEQUENT INFLATION. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19757176 ↗InjuryFeb 16, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 535CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE TISSUE EXPANDER ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT SUFFERED BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18723314 ↗InjuryOct 31, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH UNKNOWN SIZE UNKNOWN TISSUE EXPANDERS AND EXPERIENCED EXPANDER DEFLATION ON HER RIGHT SIDE. AS A RESULT, THE PATIENT IS SCHEDULED FOR AN EXCHANGE SURGERY ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18039883 ↗InjuryMay 23, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 67-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION WITH A MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE, 535CC SALINE TISSUE EXPANDER PROSTHESIS EXPERIENCED UNKNOWN SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT UNILATERAL REPLACEMENT WITH AN UNKNOWN PROSTHESIS ON (B)(6)2023.
Patient problems: Deformity/ Disfigurement; Post Operative Wound Infection
MAUDE report 16988658 ↗InjuryNov 22, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A 66-YEAR OLD FEMALE PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 535CC MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE ON THE RIGHT BREAST AND SUFFERED BREAST IMPLANT DEFLATION, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2022.
Patient problems: Deformity/ Disfigurement
MAUDE report 15844877 ↗InjuryJul 7, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT VIA MW 201022-2022-0001 THAT A 59-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH AN ARTOURA PLUS SMOOTH ULTRA HIGH PROFILE 535CC AND EXPERIENCED A DEFLATION AND AN INFECTION ON AN UNSPECIFIED SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.
Patient problems: Deformity/ Disfigurement; Post Operative Wound Infection
MAUDE report 14948922 ↗InjuryJun 17, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A 50-YEAR- OLD CAUCASIAN FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR ARTOURA PLUS SMOOTH ULTRA HIGH PROFILE 535CC BREAST IMPLANT EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT REPLACEMENT WITH ANOTHER UNKNOWN TISSUE EXPANDER ON (B)(6) 2022.
Patient problems: Deformity/ Disfigurement
MAUDE report 14733375 ↗InjuryNov 18, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 535CC ARTOURA PLUS SMOOTH ULTRA HIGH TISSUE EXPANDER EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH TWO MENTOR GEL BREAST IMPLANTS ON (B)(6) 2021.
Patient problems: Deformity/ Disfigurement
MAUDE report 12838525 ↗
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, ClassifiedArtoura 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,
Other Expander, skin, inflatable devices
- B.BRAUN 7B3050B. Braun Medical Inc. · EXPANDER, SKIN, INFLATABLE1 recall40 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549314Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE1 recall22 reports
- MENTOR CPX4 PLUS, Smooth, Medium Height SCPX146MHMentor Texas L.P. · Expander, skin, inflatable1 recall18 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MX-13-TAllergan, Inc. · Expander, Skin, Inflatable1 recall16 reports
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC135UHMentor Texas L.P. · Expander, skin, inflatable1 recall14 reports
- MENTOR ARTOURA PLUS, Smooth, High Profile SDC150HMentor Texas L.P. · Expander, skin, inflatable1 recall14 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MV-14-TAllergan, Inc. · Expander, Skin, Inflatable1 recall13 reports
- MENTOR CPX4 PLUS, Smooth, Medium Height SCPX127MHMentor Texas L.P. · Expander, skin, inflatable1 recall13 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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