MENTOR ARTOURA PLUS, Smooth, High ProfileRecalls & reported problems across all models
Mentor Texas L.P. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one MENTOR ARTOURA PLUS, Smooth, High Profile model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 58
- Deaths reported
- 0
- Injuries reported
- 44
- Recalls
- 1
We found 8 models of MENTOR ARTOURA PLUS, Smooth, High Profile by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between May 10, 2021 and Jan 16, 2026 — classified as 44 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (44 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, 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, 2026Open, Classified
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Z-1686-2026 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗
Most reported MENTOR ARTOURA PLUS, Smooth, High Profile problems
Device problems
- Material Rupture44
- Adverse Event Without Identified Device or Use Problem7
- Device Contamination with Chemical or Other Material2
- Peeled/Delaminated2
- Appropriate Device Problem Term/Code Not Available1
- Device Markings/Labelling Problem1
- Filling Problem1
- Infusion or Flow Problem1
Patient problems
- Deformity/ Disfigurement35
- No Clinical Signs, Symptoms or Conditions16
- Insufficient Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Hematoma2
- Post Operative Wound Infection2
- Fall1
MENTOR ARTOURA PLUS, Smooth, High Profile models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR ARTOURA PLUS, Smooth, High Profile SDC150HExpander, skin, inflatable1 recall14 reports
- MENTOR ARTOURA PLUS, Smooth, High Profile SDC120HExpander, skin, inflatable1 recall9 reports
- MENTOR ARTOURA PLUS, Smooth, High Profile SDC135HExpander, skin, inflatable1 recall1 report
- MENTOR ARTOURA PLUS, Smooth, High Profile SDC100HExpander, skin, inflatable1 recall0 reports
- MENTOR ARTOURA PLUS, Smooth, High Profile SDC140HExpander, skin, inflatable14 reports
- MENTOR ARTOURA PLUS, Smooth, High Profile SDC130HExpander, skin, inflatable11 reports
- MENTOR ARTOURA PLUS, Smooth, High Profile SDC110HExpander, skin, inflatable8 reports
- MENTOR ARTOURA PLUS, Smooth, High Profile SDC155HExpander, skin, inflatable1 report
Recent MENTOR ARTOURA PLUS, Smooth, High Profile adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 16, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 750CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE BREAST TISSUE EXPANDER PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT EXPANDER BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT RIGHT-SIDED EXCHANGE AND LEFT-SIDED IMPLANTATION WITH UNDISCLOSED BREAST TISSUE EXPANDERS ON (B)(6) 2025. POST-REVISION, THE SURGEON OBSERVED THE EXPLANTED DEVICE WAS COLLAPSED BUT COULD NOT FIND ANY TEARS OR LEAKS ON THE EXPANDER.
Patient problems: Deformity/ Disfigurement
MAUDE report 24099384 ↗MalfunctionJan 15, 2026Device Markings/Labelling Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 375CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE BREAST TISSUE EXPANDER. ON (B)(6) 2025, THE EXPANDER WAS REMOVED AND IT WAS NOTED THAT THE LEFT DEVICE WAS MISSING THE LOT NUMBER ENGRAVINGS. IT WAS DETERMINED THAT THE DEVICE HAD BEEN MISSING THE ENGRAVINGS AT THE TIME OF IMPLANTATION. THERE WERE NO ADVERSE EVENTS OR PATIENT HARMS/CONSEQUENCES DUE TO THE MISSING ENGRAVINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24089354 ↗InjurySep 11, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 750CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE SALINE BREAST PROSTHESIS ON AN UNSPECIFIED BREAST SIDE. POST-OPERATIVELY, THE PATIENT SUFFERED BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 23028470 ↗InjuryJun 17, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE 475CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST TISSUE EXPANDER WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL ENHANCE BREAST IMPLANT 930CC GEL BREAST PROSTHESES ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 22217092 ↗InjuryMay 21, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE 750CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE 850CC TISSUE EXPANDER ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 22064471 ↗InjuryMar 28, 2025Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture
THE FEMALE PATIENT, WHO UNDERWENT BREAST RECONSTRUCTION WITH A MENTOR ARTOURA PLUS SMOOTH, HIGH-PROFILE 375CC SALINE PROSTHESIS, IS EXPERIENCING LEFT-SIDED DEFLATION OF THE EXPANDER, INDICATIVE OF A COMPROMISED INTEGRITY LIKELY DUE TO SEPARATION ISSUES. THE SITUATION WAS FIRST SUSPECTED AFTER THE PATIENT RECEIVED FOUR FILLS, AND DESPITE NO REPORTED TRAUMA, THE EXPANDER WENT FLAT SHORTLY AFTER FILLING. UPON EXAMINATION DURING ITS REMOVAL ON THE DESIGNATED DATE, A SEPARATION BETWEEN THE BASE WITH TABS AND THE BODY OF THE EXPANDER WAS CONFIRMED. CONSEQUENTLY, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2025, TO ADDRESS THIS COMPLICATION.
Patient problems: Deformity/ Disfigurement
MAUDE report 21726182 ↗InjuryJan 6, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 375CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER PROSTHESIS. POST-OPERATIVELY, THE PATIENT FELT A "BLOWOUT" AND OBSERVED THE RIGHT BREAST WAS FLAT. A CONSULTATION WITH A MEDICAL PROFESSIONAL WAS CONDUCTED AND SHE UNDERWENT UNILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT WITH A RIGHT-SIDED 375CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 21087988 ↗MalfunctionDec 10, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A 300 CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER HAD A SPOT OF BLACK MATERIAL UPON OPENING. THE PHYSICIAN DID NOT FEEL COMFORTABLE USING THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20898614 ↗InjuryOct 23, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 500CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER DEFLATED INTRA-OPERATIVELY, DURING A BREAST RECONSTRUCTION. THERE WAS NO PATIENT CONTACT, CONSEQUENCE OR ADVERSE EVENT REPORTED.
Patient problems: Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions
MAUDE report 20518079 ↗InjuryOct 8, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 49-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 300CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE AND EXPERIENCED EXPANDER DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. PER THE INFORMATION PROVIDED, THE PATIENT HAS A HISTORY OF RIGHT BREAST CANCER, WHICH LED TO THE USE OF TISSUE EXPANDERS. THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH SERIAL NUMBERS (B)(6) ON THE LEFT SIDE, AND WITH (B)(6) ON THE RIGHT SIDE ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20404284 ↗InjuryAug 12, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 300CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19967076 ↗InjuryAug 8, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 375CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, REPLACEMENT WITH MENTOR GEL BOOST WAS PERFORMED ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19945103 ↗InjuryJul 5, 2024Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION WITH A MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE, 850CC SALINE TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION, AND DEVICE DELAMINATION POST OPERATIVE. REPORTING LEFT ARTOURA DEFLATION WITH LARGE HOLE SEPARATED AT LOWER PART OF BUFFER ZONE AND BLADDER OF EXPANDER. AS A RESULT, PATIENT UNDERWENT UNILATERAL REPLACEMENT WITH CT: SHPB-775 ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19682921 ↗InjuryJun 21, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION WITH TWO 750CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH POSSIBLE BREAST IMPLANT LEAKING. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19580997 ↗MalfunctionMay 10, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 475CC MENTOR ARTOURA PLUS, SMOOTH, HIGH PROFILE TISSUE EXPANDER WAS OBSERVED TO LEAK FLUID FROM THE BULB DURING A BREAST SURGERY PRIOR TO BEING IMPLANTED INTO THE PATIENT. THE SURGERY WAS COMPLETED; HOWEVER, THE MALFUNCTION CAUSED A 10 MINUTE SURGICAL DELAY. NO ADVERSE EVENTS OR PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19288060 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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