MENTOR ARTOURA PLUS, Smooth, Ultra High ProfileRecalls & reported problems across all models
Mentor Texas L.P. · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one MENTOR ARTOURA PLUS, Smooth, Ultra High Profile model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 56
- Deaths reported
- 0
- Injuries reported
- 49
- Recalls
- 1
We found 6 models of MENTOR ARTOURA PLUS, Smooth, Ultra High Profile by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2021 and Apr 20, 2026 — classified as 49 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (45 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
MENTOR ARTOURA PLUS, Smooth, Ultra High Profile recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 3 of these models · Recall details · FDA record ↗
Most reported MENTOR ARTOURA PLUS, Smooth, Ultra High Profile problems
Device problems
- Material Rupture45
- Adverse Event Without Identified Device or Use Problem4
- Defective Device2
- Migration2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Connection Problem1
- Device Contamination with Chemical or Other Material1
Patient problems
- Deformity/ Disfigurement43
- No Clinical Signs, Symptoms or Conditions8
- Post Operative Wound Infection4
- Hypersensitivity/Allergic reaction2
- Breast Discomfort/Pain1
- Emotional Changes1
- Hematoma1
- Impaired Healing1
MENTOR ARTOURA PLUS, Smooth, Ultra High Profile models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC120UHExpander, skin, inflatable1 recall14 reports
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC135UHExpander, skin, inflatable1 recall14 reports
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC100UHExpander, skin, inflatable1 recall0 reports
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC130UHExpander, skin, inflatable20 reports
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC140UHExpander, skin, inflatable7 reports
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC110UHExpander, skin, inflatable1 report
Recent MENTOR ARTOURA PLUS, Smooth, Ultra High Profile adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗InjuryJul 17, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WITH MENTOR ARTOURA PLUS, SMOOTH, ULTRA HIGH PROFILE TISSUE EXPANDERS EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DISCOVERED DURING EXPLANTATION. THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 22533955 ↗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 ↗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 ↗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 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 ↗
Other Mentor Texas L.P. products
- MENTOR MemoryGel Breast Implants368 models · 56,155 reports
- MENTOR MemoryGel Breast Implant211 models · 49,379 reports
- MENTOR Smooth Round Moderate Profile20 models · 14,918 reports · 1 recall
- MENTOR Smooth Round Moderate Plus Profile22 models · 6,091 reports · 1 recall
- MENTOR MemoryGel Xtra Breast Implant88 models · 5,679 reports
- MENTOR Smooth Round High Profile17 models · 4,098 reports · 1 recall
- MENTOR SILTEX Round Moderate Profile13 models · 2,160 reports
- MENTOR MemoryShape Breast Implant65 models · 1,595 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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