ARTOURA Breast Tissue Expander SMXP110RUHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00081317024378), received between Feb 24, 2020 and Mar 22, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD AFRICAN AMERICAN FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 455CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED RIGHT-SIDED EXPANDER DEFLATION POSTOPERATIVELY. THE PATIENT EXPERIENCED A SLOW LEAK, AND DEFLATION WAS DIAGNOSED VIA PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH 375CC ARTOURA BREAST TISSUE EXPANDERS, CATALOG # SMXP120RH, LEFT LOT-SERIAL # (B)(4) AND RIGHT LOT-SERIAL # (B)(4) ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11542263 ↗
• InjuryFeb 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH AN ARTOURA BREAST TISSUE EXPANDER 455CC . THE DEVICE WAS REPORTED AS A ¿FAILED EXPANDER¿ AND NO MORE ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THE SIDE IS UNKNOWN. ONCE MORE DETAILS ARE AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9745286 ↗

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