ARTOURA Breast Tissue Expander SMXP110RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00081317024293), received between Mar 4, 2021 and Mar 4, 2021 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 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, WHO'S UNDERGONE BREAST RECONSTRUCTION REVISION WITH A 300CC ARTOURA BREAST TISSUE EXPANDER ON THE RIGHT BREAST, SUFFERED BREAST PAIN, POST-PROCEDURE. IN ADDITION, THE PATIENT IS VERY SORE, ERYTHEMATOUS, AND BRUISED. THE PATIENT REPORTS THAT THE HARD BASE OF THE IMPLANT DIGS INTO THEIR SKIN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Hematoma; Local Reaction; Pain

  MAUDE report 11418340 ↗

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-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,
• 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