ARTOURA Breast Tissue Expander SMXP120RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00081317024309), received between Oct 9, 2018 and Aug 30, 2023 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A RTOURA BREAST TISSUE EXPANDER, 375CC ON THE LEFT SIDE, AND UNKNOWN TISSUE EXPANDER ON THE RIGHT SIDE, SALINE BREAST IMPLANT EXPERIENCED BILATERAL CAPSULAR CONTRACTURES UNKNOWN GRADE, AND RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: LEFT/ REF: (B)(6), SN: (B)(6), RIGHT/ REF: (B)(6), SN: (B)(6), AND LEFT BREAST OPEN CAPSULOTOMY, AND CAPSULORRHAPY ON (B)(6). 2023. THIS REPORT RELATES TO THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 17651622 ↗
• InjuryMay 21, 2022Material Rupture; Use of Device Problem; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH A 375CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A LIKE DEVICE ON (B)(6) 2022. PER MENTOR'S IFU, MENTOR'S TISSUE EXPANDER'S ARE INDICATED IMPLANTATION UP TO SIX MONTHS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14466557 ↗
• InjuryAug 4, 2020Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH AN ARTOURA BREAST TISSUE EXPANDER 375 CC DEVICE THAT DEFLATED AFTER IMPLANTATION. THE PATIENT REPORTED THAT HER LEFT BREAST TISSUE EXPANDER WOULD GO FLAT EVERY TWO WEEKS. THE DOCTOR WAS FILLING THE TISSUE EXPANDER WITH AIR, WHICH IS CONTRAINDICATED IN THE IFU. THE PATIENT ALSO SUFFERED FROM AN OPEN WOUND FOR NINE WEEKS THAT WAS NEVER FIXED. THE PATIENT WAS PLACED ON ANTIBIOTICS BECAUSE OF THE OPEN WOUND. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN ARTOURA BREAST TISSUE EXPANDER 375 CC DEVICE ON (B)(6) 2019.

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 10363551 ↗
• InjuryJun 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION WITH 375CC ARTOURA BREAST TISSUE EXPANDER HAS EXPERIENCED POSTOPERATIVE LEFT-SIDED DEFLATION, CONFIRMED BY THE SURGEON. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10131588 ↗
• InjuryApr 10, 2020Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH AN ARTOURA BREAST TISSUE EXPANDER 375CC AND EXPERIENCED DEFLATION AND INFLATION ISSUE ON THE LEFT TISSUE EXPANDER. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH NON-MENTOR BREAST IMPLANTS ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9948964 ↗
• MalfunctionMar 27, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS A HAIR FOUND INSIDE THE STERILE PACKAGING OF 375CC ARTOURA BREAST TISSUE EXPANDER. THE EXPANDER DID NOT TOUCH ANY PATIENT AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9889141 ↗
• InjuryMar 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A 375CC MENTOR ARTORA BREAST TISSUE EXPANDER AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POSTOPERATIVELY. AS A RESULT, UNDERWENT DEVICE REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED MENTOR TISSUE EXPANDER ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9818450 ↗
• MalfunctionJan 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 375CC ARTOURA BREAST TISSUE EXPANDER DEMO UNIT HAD AN OUT-OF-BOX DEFLATION DURING A DEMONSTRATION OF THE BUFFER ZONE. THERE WAS NO PATIENT CONTACT, AND THE DEVICE WAS RETURNED TO MENTOR FOR ANALYSIS.

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

  MAUDE report 9639868 ↗
• InjuryMar 8, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 375CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AFTER THE DEFLATION, THE PHYSICIAN TRIED TO RE-INFLATE THE EXPANDER BUT WAS UNSUCCESSFUL. AS A RESULT, REPLACEMENT WITH ANOTHER 375CC ARTOURA BREAST TISSUE EXPANDER WAS PERFORMED.

  Patient problems: No Code Available

  MAUDE report 8405198 ↗
• InjuryFeb 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH PRE-EXISTING BREAST CANCER UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 375CC ARTOURA BREAST TISSUE EXPANDER. LEAKING OF THE TISSUE EXPANDER IN ADDITION TO BAKER¿S GRADE I CAPSULAR CONTRACTURE WAS UPDATED POST PROCEDURE. AS A RESULT, THE DEVICE WAS REPLACED WITH A 475CC ARTOURA BREAST TISSUE EXPANDER.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8346065 ↗
• InjuryFeb 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH AN ARTOURA BREAST TISSUE EXPANDER 375CC AND EXPERIENCED DEFLATION ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED BREAST IMPLANT ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8333378 ↗
• InjuryNov 28, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH MENTOR ARTOURA BREAST TISSUE EXPANDER, 3755CC EXPANDER WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE SURGEON. AS A RESULT, PATIENT HAD THE DEVICE EXPLANTED ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8112469 ↗
• InjuryOct 9, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH AN ARTOURA BREAST TISSUE EXPANDER 375CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE. RUPTURE WAS CONFIRMED BY PHYSICIAN DURING AN EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN ARTOURA BREAST TISSUE EXPANDER 375CC, CATALOG NUMBER SMXP120RH, SERIAL NUMBER (B)(4), LOT NUMBER 7615733 ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7947828 ↗

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