Mentor Texas
FDA adverse event reports naming Mentor Texas as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MENTOR TEXAS.
- Total reports
- 117,150
- Deaths
- 0
- Injuries
- 115,010
- Malfunctions
- 2,138
Reports per year
Source: FDA adverse event reports by year received, 1999–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-FilledFTR74,930
- Prosthesis, Breast, Inflatable, Internal, SalineFWM39,762
- Tissue Expander And AccessoriesLCJ2,315
- System, Suction, LipoplastyMUU97
- Mammary SizerMRD26
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorOTN7
- Product code ------3
- Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)LJC3
- Mesh, Surgical, PolymericFTL2
- Mesh, SurgicalFTM2
Recent recalls
- 2026-06-26Open, ClassifiedProcess control
SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
A single lot of expired syringes were distributed due to a distribution system control failure.
- 2026-03-27Open, ClassifiedUnder Investigation by firm
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- 2026-03-27Open, ClassifiedUnder Investigation by firm
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- 2026-03-27Open, ClassifiedUnder Investigation by firm
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- 2026-03-27Open, ClassifiedUnder Investigation by firm
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- 2026-03-27Open, ClassifiedUnder Investigation by firm
Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- 2026-03-27Open, ClassifiedUnder Investigation by firm
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, 475cc, 500cc, 600cc, 750cc, 850cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- 2026-03-27Open, ClassifiedUnder Investigation by firm
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, 700cc, 850cc
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- 2017-05-11TerminatedOther
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Missing Dome Pack accessory.
- 2016-09-10TerminatedEmployee error
Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
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