ARTOURA Breast Tissue Expander SMXP100RUHRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00081317024361), received between Dec 20, 2019 and Jun 16, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

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.

• InjuryJun 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 350CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14721676 ↗
• InjuryAug 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 350CC ARTOURA BREAST TISSUE EXPANDER PROSTHESIS AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION. A HEALTHCARE PROFESSIONAL STATED THAT THE PATIENT¿S TISSUE EXPANDER WAS NOT RETAINING FLUID. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 350CC ARTOURA BREAST TISSUE EXPANDER PROSTHESIS ( RIGHT CATALOG #: SMXP100RUH, RIGHT SERIAL #: (B)(4)) ON (B)(6) 2021. UPON EXPLANTATION, THE RIGHT-SIDED DEVICE WAS OBSERVED TO BE DEFLATED, AND THE DIAGNOSIS WAS CONFIRMED BY HER SURGEON.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12356603 ↗
• InjuryDec 20, 2019Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A 350CC MENTOR ARTOURA BREAST TISSUE EXPANDER THAT EXHIBITED ISSUES WITH THE ADDITION OF EXPANSION FLUID POSTOPERATIVELY. DURING ONE OF THE PATIENT¿S RECONSTRUCTION STAGES, WHEN THE PHYSICIAN WAS ATTEMPTING TO FURTHER INFLATE THE DEVICE, SALINE COULD NOT BE ADDED. THE PHYSICIAN NOTED THAT THE DEVICE BEHAVED AS IF IT WERE SEALED. AS A RESULT, THE DEVICE WAS EXPLANTED AT THIS TIME, ON (B)(6)2019. IT IS NOT CURRENTLY KNOWN IF THE DEVICE WAS IMMEDIATELY REPLACED.

  Patient problems: No Code Available

  MAUDE report 9500461 ↗

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,