MENTOR ARTOURA PLUS, Smooth, High Profile SDC155HRecalls & reported problems
Mentor Texas L.P. · Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 850cc · Class U · Implant
All models of MENTOR ARTOURA PLUS, Smooth, High Profile (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10081317028151), received between Jul 5, 2024 and Jul 5, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Rupture” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K161176); they may or may not involve this specific model.
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 Rupture1
- Peeled/Delaminated1
Patient problems
- Deformity/ Disfigurement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K161176. One submission often covers many models, so check the product and lot details in each record.
- Z-1687-2026 · Feb 18, 2026 · Open, ClassifiedArtoura 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
- Z-1686-2026 · Feb 18, 2026 · Open, ClassifiedArtoura 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,
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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