ARTOURA Breast Tissue Expander SMXP100RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00081317024286), received between Jul 13, 2020 and May 26, 2021 — classified as 2 injuries, 1 malfunction.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION SURGERY WITH A 225CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED RIGHT SIDED PATIENT DISSATISFACTION WITH PROCEDURAL OUTCOME POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11891448 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH AN ARTOURA BREAST TISSUE EXPANDER 225CC AND SUFFERED FROM SURGICAL INTERVENTION, CAPSULAR CONTRACTURE AND AN INFECTION ON THE RIGHT BREAST IMPLANT. THE PATIENT EXPERIENCED HIGH PAIN LEVEL, BACK PAIN, HIGH BLOOD PRESSURE, HOSPITALIZATION DUE TO MUSCLE SWELLING AND IT WAS FEELING HOT, CANNOT SLEEP DUE TO PAIN, ALL THE FLUID WAS IN THE TOP TWO THIRDS AND NEVER WENT DOWN, SPASMING, THE PATIENT IS UPSET ABOUT EVERYTHING, THE PATIENT HAS TO USE HER LEFT ARM FOR EVERYTHING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Contracture; Post Operative Wound Infection

  MAUDE report 11124734 ↗
• MalfunctionJul 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT AN ARTOURA BREAST TISSUE EXPANDER 225CC BEING USED IN A BREAST RECONSTRUCTION WAS FOUND TO BE DEFLATED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10266304 ↗

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, Classified
  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
• Z-1686-2026 · Feb 18, 2026 · Open, Classified
  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,