MENTOR ARTOURA PLUS, Smooth, High Profile SDC135HRecalls & reported problems
Mentor Texas L.P. · Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 500cc · Class U · Implant
All models of MENTOR ARTOURA PLUS, Smooth, High Profile (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10081317028250), received between Oct 23, 2024 and Oct 23, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Rupture” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall 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
Recalls naming this device
- Feb 18, 2026Class IIOpen, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Rupture1
Patient problems
- Deformity/ Disfigurement1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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
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 · each recall links to the FDA recall notice
- 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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