ARTOURA Breast Tissue Expander SMXP135RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00081317024323), received between Feb 21, 2018 and Nov 17, 2021 — classified as 13 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WITH AN ARTOURA BREAST TISSUE EXPANDER 500CC AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED SALINE TISSUE EXPANDER ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12832673 ↗
• InjuryJul 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 500CC ARTOURA BREAST TISSUE EXPANDER ON THE LEFT BREAST, SUFFERED LEFT BREAST IMPLANT DEFLATION, POST-PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL ON (B)(6) 2020 AND REPLACEMENT WITH THE FOLLOWING DEVICES: (LEFT) 595CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: SHPX595 LOT: 7738926 SN: (B)(4) AND (RIGHT) 595CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: SHPX595 LOT: 7727815 SN: (B)(4).

  Patient problems: No Code Available

  MAUDE report 10255784 ↗
• InjuryMay 26, 2020Off-Label Use; Migration; Off-Label Use; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH ARTOURA BREAST TISSUE EXPANDER 500CC DEVICES SUFFERED FROM IRRITATION IN BOTH BREASTS. THE PATIENT EXPRESSED THE POSSIBILITY OF A METAL OR SILICONE ALLERGY. IN ADDITION, THE PATIENT REPORTED THAT THE DEVICES WERE CONSTANTLY SHIFTING IN HER BREASTS AND THAT SHE FELT PAIN FROM THE METAL PORT STICKING OUT IN PLACES LIKE UNDER HER ARMPIT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 755CC GEL BREAST PROSTHESES ON (B)(6) 2020. THE PATIENT¿S EXPLANTATION SURGERY WAS DELAYED BECAUSE OF COVID-19 RESTRICTIONS. BECAUSE OF THIS, THE PATIENT¿S RIGHT TISSUE EXPANDER WAS IMPLANTED IN THE PATIENT FOR LONGER THAN 6 MONTHS, WHICH IS CONTRAINDICATED IN THE IFU. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Local Reaction; No Code Available

  MAUDE report 10088677 ↗
• InjuryMay 26, 2020Migration; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH ARTOURA BREAST TISSUE EXPANDER 500CC DEVICES SUFFERED FROM IRRITATION IN BOTH BREASTS. THE PATIENT EXPRESSED THE POSSIBILITY OF A METAL OR SILICONE ALLERGY. IN ADDITION, THE PATIENT REPORTED THAT THE DEVICES WERE CONSTANTLY SHIFTING IN HER BREASTS AND THAT SHE FELT PAIN FROM THE METAL PORT STICKING OUT IN PLACES LIKE UNDER HER ARMPIT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 755CC GEL BREAST PROSTHESES ON (B)(6) 2020. THE PATIENT¿S EXPLANTATION SURGERY WAS DELAYED BECAUSE OF COVID-19 RESTRICTIONS. BECAUSE OF THIS, THE PATIENT¿S RIGHT TISSUE EXPANDER WAS IMPLANTED IN THE PATIENT FOR LONGER THAN 6 MONTHS, WHICH IS CONTRAINDICATED IN THE IFU. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Local Reaction; No Code Available

  MAUDE report 10088676 ↗
• InjuryMay 19, 2020Adverse 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 UNDERWENT UNSPECIFIED BREAST RECONSTRUCTION SURGERY WITH 500CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED WOUND INFECTION ON HER LEFT SIDE POSTOPERATIVELY. THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER SMXP135RH; SERIAL NUMBER (B)(4) ON THE LEFT SIDE AND WITH CATALOG NUMBER SMXP135RH; SERIAL NUMBER (B)(4) ON THE RIGHT SIDE ON (B)(6) 2019.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10070265 ↗
• InjuryMar 3, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 500CC ARTOURA BREAST TISSUE EXPANDER ON THE RIGHT BREAST, SUFFERED BREAST IMPLANT DEFLATION, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A NON-MENTOR SILICONE IMPLANT ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9780548 ↗
• InjuryJan 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT BREAST SURGERY WITH AN ARTOURA BREAST TISSUE EXPANDER 500CC DEVICE THAT DEFLATED AFTER IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9639245 ↗
• InjuryDec 16, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN (B)(6) PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 500CC MENTOR ARTOURA BREAST TISSUE EXPANDER AND A MENTOR CPX4 WITH SUTURE TABS MEDIUM HEIGHT SMOOTH EXPANDER AND EXPERIENCED POSTOPERATIVE BILATERAL DEFLATION. AS A RESULT, THE PATIENT'S DEVICES WERE EXPLANTED ON (B)(6) 2019.THIS REPORT IS FOR THE PATIENT'S MENTOR ARTOURA BREAST TISSUE EXPANDER.

  Patient problems: No Code Available

  MAUDE report 9475283 ↗
• InjuryDec 2, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WITH AN ARTOURA BREAST TISSUE EXPANDER 500CC AND EXPERIENCED DEFLATION (SIDE UNKNOWN). AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9396266 ↗
• InjuryMar 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH AN ARTOURA BREAST TISSUE EXPANDER 500CC AND EXPERIENCED DEFLATION (SIDE UNKNOWN). AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8453257 ↗
• InjuryFeb 27, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH ARTOURA BREAST TISSUE EXPANDER 500CC AND EXPERIENCED DEFLATION ON THE RIGHT TISSUE EXPANDER. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8374766 ↗
• InjuryDec 4, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH AN ARTOURA BREAST TISSUE EXPANDER 500CC FILLED TO 800CC AND EXPERIENCED DEFLATION ON THE LEFT SIDE. DEFLATION WAS CONFIRMED BY PHYSICIAN DURING EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN ARTOURA BREAST TISSUE EXPANDER 500CC, CATALOG NUMBER: SMXP135RH, SERIAL NUMBER: (B)(4), LOT NUMBER: 7607879 ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8130159 ↗
• MalfunctionNov 15, 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 SECOND OF FOUR MENTOR ARTOURA BREAST TISSUE EXPANDER DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8076174 ↗
• MalfunctionNov 15, 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 FIRST OF FOUR MENTOR ARTOURA BREAST TISSUE EXPANDER DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8076160 ↗
• InjuryJul 30, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH AN ARTOURA BREAST TISSUE EXPANDER 500CC AND EXPERIENCED DEFLATION ON THE RIGHT TISSUE EXPANDER. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH A ARTOURA BREAST TISSUE EXPANDER 500CC ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7733525 ↗
• MalfunctionFeb 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) PATIENT WAS BEING PREPARED FOR A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A ARTOURA BREAST TISSUE EXPANDER 500CC THAT DEFLATED DURING SURGERY. DEFLATION WAS DISCOVERED PRIOR TO IMPLANTATION AND THE DEVICE NEVER CAME INTO CONTACT WITH THE PATIENT. USER FACILITY HAD A BACKUP DEVICE AND THE PROCEDURE WAS COMPLETED WITH NO DELAY. THE DEFLATED DEVICE WILL BE RETURNED TO MENTOR FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287938 ↗

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