ARTOURA Breast Tissue Expander TEXP135RUHRecalls & reported problems
Mentor Texas L.P. · Textured, Ultra High Profile, Suture Tabs, Integral Injection Dome 700cc · Class U · Implant
All models of ARTOURA Breast Tissue Expander (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00081317009566), received between May 7, 2018 and Sep 14, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Material Rupture” (3 reports).
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
Most reported problems
Device problems
- Material Rupture3
Patient problems
- No Code Available2
- Deformity/ Disfigurement1
Recent adverse event reports
The 3 most recent of 3 reports, 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 ↗InjurySep 5, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH AN ARTOURA BREAST TISSUE EXPANDER 700CC AND EXPERIENCED DEFLATION ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019.
Patient problems: No Code Available
MAUDE report 8964935 ↗InjuryMay 7, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) -YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR ARTOURA BREAST TISSUE EXPANDER 700CC THAT DEFLATED AFTER IMPLANTATION. DEFLATION WAS DISCOVERED DURING SURGERY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 685CC GEL BREAST PROSTHESIS ON (B)(6) 2018.
Patient problems: No Code Available
MAUDE report 7493193 ↗
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
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC120UHMentor 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
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
- 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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