ARTOURA Breast Tissue Expander SMXP135RUHRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00081317024408), received between Nov 19, 2018 and Nov 18, 2021 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH 700CC ARTOURA BREAST TISSUE EXPANDERS EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. THE DEFLATIONS WERE DIAGNOSED THROUGH A PHYSICAL EXAMINATION. THE RIGHT EXPANDER WAS INFLATED TO 450CCS AT THE TIME OF THE DEFLATION. THE LEFT SIDED DEFLATION IS LESS PRONOUNCED AND LEAKING MORE SLOWLY. AS A RESULT, EXPLANT AND REPLACEMENT WITH UNSPECIFIED IMPLANTS WAS PERFORMED ON (B)(6) 2021. THE RIGHT SIDED DEFLATION WAS REPORTED INITIALLY UNDER 1645337-2021-10393 ON (B)(6) 2021. ON OCTOBER 27, 2021 MENTOR RECEIVED ADDITIONAL INFORMATION AND INITIAL AWARENESS OF BILATERAL ISSUES. THIS REPORT RELATES TO THE LEFT PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12841082 ↗
• InjurySep 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 700CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. THE DEVICE WAS INFLATED TO 450CCS AT THE TIME OF THE DEFLATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12485995 ↗
• InjuryApr 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 700CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON AN UNKNOWN SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021. IT IS UNKNOWN WHICH SIDE WAS IMPACTED, BUT MENTOR WAS PROVIDED WITH THE LOT AND SERIAL NUMBERS ((B)(4)) FOR THE PATIENT¿S IMPLANTED DEVICES. IF CLARIFICATION IS RECEIVED INDICATING WHICH SIDE WAS IMPACTED, A SUPPLEMENTAL REPORT WILL BE SENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11624916 ↗
• InjuryJul 2, 2020Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 700CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED POSTOPERATIVE LEFT-SIDED DEFLATION. THE PATIENT HAD A CONSULTATION ON (B)(6) 2019, AND THE DEFLATION WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. SINCE THE DEVICE WAS LEFT IN FOR OVER SIX MONTHS, IT WAS USED IN A MANNER INCONSISTENT WITH THE PRODUCT INSERT DATA SHEET. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10226246 ↗
• InjuryApr 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 700CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THERE WAS A HOLE IN THE TISSUE EXPANDER. AS A RESULT, THE DEVICE WAS REPLACED WITH ANOTHER 700CC ARTOURA BREAST TISSUE EXPANDER ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10006226 ↗
• InjuryMar 27, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH AN ARTOURA BREAST TISSUE EXPANDER 700CC DEVICE THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST TISSUE EXPANDER WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN ARTOURA BREAST TISSUE EXPANDER 700CC DEVICE ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9889235 ↗
• InjuryJan 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH MENTOR ARTOURA BREAST TISSUE EXPANDER, 700CC SALINE IMPLANTS WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. AS A RESULT PATIENT HAD THE EXPANDER REMOVED ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9637590 ↗
• InjuryJun 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 700CC ARTOURA BREAST TISSUE EXPANDER ON THE LEFT SIDE, SUFFERED DEFLATION POST-OPERATIVELY. AS A RESULT, THE PATIENT WAS SCHEDULED FOR IMPLANT EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8669142 ↗
• MalfunctionFeb 1, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST RECONSTRUCTION SURGERY WITH MENTOR ARTOURA BREAST TISSUE EXPANDER, 700CC DEVICES, WHICH INTRAOPERATIVELY LEAK FOUND WHEN TRYING TO IMPLANT. IT TOOK ABOUT TWENTY MINUTES TO NOTICE THE ISSUE AND CALL FOR THE NEW IMPLANT. THE IMPLANT REPLACED WITH CATALOG NUMBER SMXP135RUH, SERIAL NUMBER (B)(4) ON (B)(6) 2018. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8299320 ↗
• InjuryJan 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT BILATERAL RECONSTRUCTION WITH A MENTOR ARTOURA BREAST TISSUE EXPANDER 700CC ON (B)(6) 2018 PRESENTED WITH RIGHT BREAST ERYTHEMA ON (B)(6) 2018. THE PATIENT HAD AN INFECTIOUS DISEASE CONSULT AND SHE DID NOT RESPOND TO IV ANTIBIOTICS. THE PATIENT RETURNED TO THE OR ON 11/16/2018 WHERE SHE UNDERWENT REMOVAL OF THE RIGHT TISSUE EXPANDER, DRAINAGE OF THE ABSCESS AND WOUND DEBRIDEMENT. THE PATIENT DID HAVE A PORT A CATH INFECTION AND REMOVED IN ON (B)(6) 2018.

  Patient problems: Abscess; No Code Available

  MAUDE report 8248784 ↗
• InjuryDec 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, A MENTOR ARTOURA BREAST TISSUE EXPANDER 700CC DEVICE WAS RECEIVED BY THE MENTOR PRODUCT ANALYSIS LAB WITH NO ACCOMPANYING INFORMATION. THE DEVICE COULD NOT BE ASSOCIATED WITH AN EXISTING COMPLAINT. ANALYSIS ON THIS DEVICE HAS BEGUN, BUT IS NOT COMPLETE YET. IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHY THIS DEVICE WAS RETURNED TO MENTOR. HOWEVER, THE RETURN OF A TISSUE EXPANDER IS CHARACTERISTIC OF A REMOVAL AND REPLACEMENT. AS A RESULT, THIS WILL BE CONSERVATIVELY REPORTED TO FDA.

  Patient problems: No Code Available

  MAUDE report 8205410 ↗
• MalfunctionNov 19, 2018Delivered as Unsterile Product; Device Damaged Prior to Receipt by User; Delivered as Unsterile Product; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT FOUR MENTOR TISSUE EXPANDER DEVICES (TWO ARTOURA BREAST TISSUE EXPANDER 500CC DEVICES, ONE ARTOURA BREAST TISSUE EXPANDER 535CC DEVICE, AND ONE ARTOURA BREAST TISSUE EXPANDER 700CC DEVICE) ARRIVED DAMAGED. THE OUTER SHIPPING BOX WAS SEVERELY DAMAGED AND APPEARED TO BE TAPED TOGETHER. THE DAMAGE TO THE DEVICE PACKAGING WAS NOT NOTICED UNTIL THE SHIPPING BOX WAS OPENED. DEVICE STERILITY WAS COMPROMISED. THE FOUR DEVICES WERE DESTROYED AND WERE NEVER USED IN A PATIENT. THERE WAS NO PATIENT CONTACT. THIS MEDWATCH REPORT IS FOR THE FOURTH OF FOUR MENTOR ARTOURA BREAST TISSUE EXPANDER DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8087969 ↗

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