ARTOURA Breast Tissue ExpanderRecalls & reported problems across all models
Mentor Texas L.P. · 28 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one ARTOURA Breast Tissue Expander model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 300
- Deaths reported
- 0
- Injuries reported
- 269
- Recalls
- 1
We found 28 models of ARTOURA Breast Tissue Expander by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 300 adverse event reports in the FDA's MAUDE database, received between Feb 21, 2018 and Sep 14, 2026 — classified as 269 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (239 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
ARTOURA Breast Tissue Expander 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-1685-2026 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗
Most reported ARTOURA Breast Tissue Expander problems
Device problems
- Material Rupture239
- Adverse Event Without Identified Device or Use Problem31
- Off-Label Use13
- Material Separation7
- Defective Device5
- Migration5
- Connection Problem4
- Delivered as Unsterile Product4
Patient problems
- No Code Available191
- Deformity/ Disfigurement56
- No Consequences Or Impact To Patient18
- Post Operative Wound Infection13
- No Clinical Signs, Symptoms or Conditions12
- Capsular Contracture6
- No Patient Involvement6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
ARTOURA Breast Tissue Expander models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ARTOURA Breast Tissue Expander TEXP120RUHEXPANDER, SKIN, INFLATABLE1 recall12 reports
- ARTOURA Breast Tissue Expander TEXP135RHEXPANDER, SKIN, INFLATABLE1 recall8 reports
- ARTOURA Breast Tissue Expander TEXP150RHEXPANDER, SKIN, INFLATABLE1 recall7 reports
- ARTOURA Breast Tissue Expander TEXP110RHEXPANDER, SKIN, INFLATABLE1 recall5 reports
- ARTOURA Breast Tissue Expander SMXP150RHEXPANDER, SKIN, INFLATABLE42 reports
- ARTOURA Breast Tissue Expander SMXP140RHEXPANDER, SKIN, INFLATABLE32 reports
- ARTOURA Breast Tissue Expander TEXP140RHEXPANDER, SKIN, INFLATABLE19 reports
- ARTOURA Breast Tissue Expander SMXP130RHEXPANDER, SKIN, INFLATABLE19 reports
- ARTOURA Breast Tissue Expander SMXP155RHEXPANDER, SKIN, INFLATABLE19 reports
- ARTOURA Breast Tissue Expander SMXP135RHEXPANDER, SKIN, INFLATABLE16 reports
- ARTOURA Breast Tissue Expander SMXP120RHEXPANDER, SKIN, INFLATABLE13 reports
- ARTOURA Breast Tissue Expander SMXP130RUHEXPANDER, SKIN, INFLATABLE12 reports
- ARTOURA Breast Tissue Expander SMXP135RUHEXPANDER, SKIN, INFLATABLE12 reports
- ARTOURA Breast Tissue Expander TEXP120RHEXPANDER, SKIN, INFLATABLE11 reports
- ARTOURA Breast Tissue Expander SMXP120RUHEXPANDER, SKIN, INFLATABLE11 reports
- ARTOURA Breast Tissue Expander SMXP140RUHEXPANDER, SKIN, INFLATABLE11 reports
- ARTOURA Breast Tissue Expander TEXP130RHEXPANDER, SKIN, INFLATABLE10 reports
- ARTOURA Breast Tissue Expander TEXP130RUHEXPANDER, SKIN, INFLATABLE10 reports
- ARTOURA Breast Tissue Expander TEXP140RUHEXPANDER, SKIN, INFLATABLE7 reports
- ARTOURA Breast Tissue Expander TEXP155RHEXPANDER, SKIN, INFLATABLE5 reports
- ARTOURA Breast Tissue Expander TEXP110RUHEXPANDER, SKIN, INFLATABLE3 reports
- ARTOURA Breast Tissue Expander TEXP135RUHEXPANDER, SKIN, INFLATABLE3 reports
- ARTOURA Breast Tissue Expander SMXP100RHEXPANDER, SKIN, INFLATABLE3 reports
- ARTOURA Breast Tissue Expander SMXP100RUHEXPANDER, SKIN, INFLATABLE3 reports
- ARTOURA Breast Tissue Expander TEXP100RHEXPANDER, SKIN, INFLATABLE2 reports
- ARTOURA Breast Tissue Expander TEXP100RUHEXPANDER, SKIN, INFLATABLE2 reports
- ARTOURA Breast Tissue Expander SMXP110RUHEXPANDER, SKIN, INFLATABLE2 reports
- ARTOURA Breast Tissue Expander SMXP110RHEXPANDER, SKIN, INFLATABLE1 report
Recent ARTOURA Breast Tissue Expander adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Material Rupture
It was reported that a patient underwent a Breast Reconstruction Surgery with implantation of a 700cc ARTOURA Breast Tissue Expander prosthesis. Post-operatively, the patient was diagnosed with a deflated right implant by a medical professional. As a result, the patient underwent right-sided exchange with a non-Mentor tissue expander on (b)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50757627 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent breast reconstruction with two 600cc ARTOURA Breast Tissue Expanders. Post-operatively, the patient suffered bilateral breast infection. As a result, the patient underwent breast implant removal and replacement surgery on (b)(6)2026. The replacement devices were two Mentor gel implants.This Medwatch form is for the right breast prosthesis.
Patient problems: Post Operative Wound Infection
MAUDE report 50078092 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent breast reconstruction with two 600cc ARTOURA Breast Tissue Expanders. Post-operatively, the patient suffered bilateral breast infection. As a result, the patient underwent breast implant removal and replacement surgery on (b)(6) 2026. The replacement devices were two Mentor gel implants.This Medwatch form is for the left breast prosthesis.
Patient problems: Post Operative Wound Infection
MAUDE report 50078090 ↗InjuryJun 2, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 600CC ARTOURA BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED EXPANDER OF AN UNDISCLOSED SIDE BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT EXPANDER REMOVAL ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 25365980 ↗InjuryJan 9, 2026Material Rupture; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROTHESIS IMPLANTATION WITH A 750CC ARTOURA BREAST TISSUE EXPANDER ON AN UNSPECIFIED BREAST SIDE. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BREAST IMPLANT SLOW LEAK. IT WAS ALSO NOTED DURING THE SURGERY THAT THERE WAS A SILICONE FLAW AT THE ATTACHMENT OF THE REINFORCED EDGE NEAR THE LATERAL TAB. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 24026644 ↗InjuryDec 23, 2025Material Rupture; Material Rupture
A FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION WITH MENTOR ARTOURA BREAST TISSUE EXPANDER, 850CC SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST OPERATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REPLACEMENT WITH LOT: 2055391 ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 23881351 ↗InjuryDec 11, 2025Material Rupture; Connection Problem; Material Rupture; Connection Problem
IT WAS REPORTED THAT A PATIENT WITH ARTOURA BREAST TISSUE EXPANDERS EXPERIENCED SEROMA AND DEFLATION (SIDE UNKNOWN) POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. UPON EXPLANTATION ON AN UNSPECIFIED DATE, IT WAS DISCOVERED THE INJECTION PORT WAS DEFECTIVE.
Patient problems: Seroma
MAUDE report 23785475 ↗InjuryOct 29, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH ARTOURA BREAST TISSUE EXPANDER 750CC AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A MENTOR GEL BREAST IMPLANT ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20561377 ↗InjuryOct 7, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR ARTOURA BREAST TISSUE EXPANDER, 650CC SALINE PROSTHESIS EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVE. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20390053 ↗InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A 47-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 475CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED WOUND INFECTION ON HER LEFT SIDE POSTOPERATIVELY. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. THE PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY WITH CATALOG NUMBER 3502700; SERIAL NUMBER (B)(6) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3502700; SERIAL NUMBER (B)(6) ON THE RIGHT SIDE ON (B)(6) 2024.
Patient problems: Post Operative Wound Infection
MAUDE report 18999368 ↗InjuryDec 28, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 650CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 18411830 ↗MalfunctionNov 9, 2023Connection Problem; Connection Problem
IT WAS REPORTED THAT A 475CC ARTOURA BREAST TISSUE EXPANDER AND AN UNKNOWN MENTOR TISSUE EXPANDER WERE OBSERVED TO HAVE DEFECTIVE VALVES PRIOR TO AN UNSPECIFIED BREAST SURGERY. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO REPORTED ADVERSE EVENTS OR PATIENT OUTCOMES WERE REPORTED. THIS REPORT IS FOR THE FIRST OF TWO IMPLANTS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-13351 FOR THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18107258 ↗MalfunctionOct 3, 2023Filling Problem; Filling Problem
IT WAS REPORTED THAT A 650CC ARTOURA BREAST TISSUE EXPANDER BEING USED IN A PROCEDURE WAS HAVING DIFFICULTY WITH EXPANSION; UPON OPENING THE EXPANDER, IT WAS UNABLE TO BE FILLED. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17863302 ↗InjurySep 21, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 63-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 500CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 17790001 ↗InjuryAug 30, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A RTOURA BREAST TISSUE EXPANDER, 375CC ON THE LEFT SIDE, AND UNKNOWN TISSUE EXPANDER ON THE RIGHT SIDE, SALINE BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURES UNKNOWN GRADE, AND RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: LEFT/ REF: (B)(6), SN: (B)(6), RIGHT/ REF: (B)(6), SN: (B)(6), AND LEFT BREAST OPEN CAPSULOTOMY, AND CAPSULORRHAPY ON (B)(6). 2023. THIS REPORT RELATES TO THE LEFT SIDE.
Patient problems: Capsular Contracture
MAUDE report 17651622 ↗
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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