ARTOURA Breast Tissue Expander SMXP155RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00081317024354), received between Mar 28, 2018 and Mar 31, 2022 — classified as 19 injuries.

The most frequently reported specific device problem is “Material Rupture” (17 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) BLACK FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 850CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13966703 ↗
• InjuryFeb 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE THAT AN ARTOURA BREAST TISSUE EXPANDER 850CC DEVICE WHICH DEFLATED AFTER IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST TISSUE EXPANDER WAS OBSERVED DURING A REMOVAL SURGERY ON (B)(6) 2021. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH UNKNOWN IMPLANTS ON THE SAME DAY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11379565 ↗
• InjuryFeb 17, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH 850CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED RIGHT-SIDED EXPANDER DEFLATION POSTOPERATIVELY. THE PATIENT HAD FOUR SUBSEQUENT FILLS TO THE VOLUME OF 400CC, AND DEFLATION WAS DIAGNOSED VIA PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11341005 ↗
• InjuryJan 6, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 850CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED EXPANDER DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY DIAGNOSED VIA PHYSICAL EXAM. THE EXPANDER WAS IMPLANTED OFF LABEL FOR MORE THAN SIX MONTHS. THE EXPANDER WAS EXPLANTED ON (B)(6) 2020.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11124001 ↗
• InjuryDec 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH AN ARTOURA BREAST TISSUE EXPANDER 850CC DEVICE THAT DEFLATED AFTER IMPLANTATION. THE PATIENT NOTICED A LEAK IN HER LEFT BREAST TISSUE EXPANDER ON (B)(6) 2020. IN ADDITION, THE PATIENT DEVELOPED A SEROMA WITH EARLY ONSET CELLULITIS IN HER LEFT BREAST. A SEROMA CATHETER WAS PLACED TO DRAIN THE SEROMA ON (B)(6) 2020 WHICH MAY HAVE PUNCTURED THE TISSUE EXPANDER. A CULTURE WAS COLLECTED OF THE SEROMA FLUID AND IT WAS SENT TO PATHOLOGY FOR TESTING. PATHOLOGY RESULTS SHOWED NO GROWTH. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN ARTOURA BREAST TISSUE EXPANDER 850CC DEVICE ON (B)(6) 2020.

  Patient problems: Post Operative Wound Infection; Seroma

  MAUDE report 11098418 ↗
• InjurySep 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT OF AN UNKNOWN AGE, RACE, AND ETHNICITY UNDERWENT UNSPECIFIED BREAST SURGERY WITH A 850CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED LEFT SIDE EXPANDER DEFLATION POSTOPERATIVELY. AS A RESULT, THE EXPANDER WAS EXPLANTED ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10505401 ↗
• InjurySep 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH AN ARTOURA BREAST TISSUE EXPANDER 850 CC AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A MENTOR TISSUE EXPANDER (SERIAL NUMBER (B)(4)) ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10503065 ↗
• InjuryAug 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR ARTOURA BREAST TISSUE EXPANDER 850CC SALINE DEVICE WHICH PATIENT EXPERIENCED BILATERAL DEFLATION AFTER IMPLANTATION. LEFT EXPANDER HAD A LEAK FROM WHERE THE VALVE EXPANDS ITSELF. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. AS A RESULT PATIENT HAD THE LEFT DEVICE REMOVED AND REPLACED WITH ANOTHER DEVICE ON (B)(6) 2019. ON (B)(6) 2020, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT POST-OP FOLLOW UP ON (B)(6) 2019 DEMONSTRATED DEFLATING RIGHT BREAST EXPANDER. IMMEDIATE NEW FLUID COLLECTION WAS NOTED OF THE RIGHT BREAST. SUPERFICIAL ASPIRATION REMOVED 60 CC. THIS IS CONFIRMING A LEAK OF THE EXPANDER. ON (B)(6) 2019 BILATERAL BREAST REPLACEMENT OF TISSUE EXPANDER WITH PERMANENT SILICONE IMPLANTS WITH CAT#: 3508004BC PERFORMED. THIS REPORT IS FOR THE RIGHT SIDE.

  Patient problems: No Code Available

  MAUDE report 10373729 ↗
• InjuryMay 27, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 850CC ARTOURA BREAST TISSUE EXPANDER PROSTHESIS AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION. A HEALTHCARE PROFESSIONAL STATED THAT THE PATIENT¿S EXPANDER WAS COLLAPSED AND DRAINED. AS A RESULT, THE PATIENT HAD THE DEVICE EXPLANTED ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10094110 ↗
• InjuryDec 1, 2019Material Rupture; Defective Component; Appropriate Device Problem Term/Code Not Available; Material Rupture; Defective Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH 850CC ARTOURA BREAST TISSUE EXPANDER AND WAS PRESENTED WITH RIGHT SIDE DEFLATION AFTER IMPLANTATION. EXPANDER HAD A LEAK FROM WHERE THE VALVE EXPANDS ITSELF. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. AS A RESULT PATIENT HAD THE DEVICE REMOVED AND REPLACED WITH ANOTHER DEVICE ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9392664 ↗
• InjuryNov 11, 2019Material Rupture; Defective Component; Material Rupture; Defective Component

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR ARTOURA BREAST TISSUE EXPANDER 850CC SALINE DEVICE WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. EXPANDER HAD A LEAK FROM WHERE THE VALVE EXPANDS ITSELF. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. AS A RESULT PATIENT HAD THE DEVICE REMOVED AND REPLACED WITH ANOTHER DEVICE ON (B)(6)2019.

  Patient problems: No Code Available

  MAUDE report 9305954 ↗
• InjuryNov 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH AN 850CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, UNILATERAL PROSTHESIS REPLACEMENT WITH AN UNKNOWN DEVICE WAS PERFORMED. THE PATIENT HAS FULLY RECOVERED WITH NO RESIDUAL EFFECTS.

  Patient problems: No Code Available

  MAUDE report 9293349 ↗
• InjuryJul 10, 2019Material Separation; Migration; Material Separation; Migration

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE WHO HAD 850CC ARTOURA BREAST TISSUE EXPANDERS PLACED EXPERIENCED RIGHT SIDED DEFLATION AND LEFT SIDED ROTATION POST PROCEDURE. THE RIGHT SIDED SUTURE TAB TORE AWAY FROM THE SHELL, AND LEFT SIDED SUTURES TORE. AS A RESULT, BILATERAL REPLACEMENT WITH 850CC ARTOURA BREAST TISSUE EXPANDERS WAS PERFORMED. THIS REPORT RELATES TO THE LEFT PROSTHESIS. SEE 1645337-2019-15166 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: No Code Available

  MAUDE report 8778711 ↗
• InjuryJul 10, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE WHO HAD 850CC ARTOURA BREAST TISSUE EXPANDERS PLACED EXPERIENCED RIGHT SIDED DEFLATION AND LEFT SIDED ROTATION POST PROCEDURE. THE RIGHT SIDED SUTURE TAB TORE AWAY FROM THE SHELL, AND LEFT SIDED SUTURES TORE. AS A RESULT, BILATERAL REPLACEMENT WITH 850CC ARTOURA BREAST TISSUE EXPANDERS WAS PERFORMED. THIS REPORT RELATES TO THE RIGHT PROSTHESIS. SEE 1645337-2019-15167 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: No Code Available

  MAUDE report 8778709 ↗
• InjuryJun 20, 2019Material Rupture; Connection Problem; Material Rupture; Connection Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 850CC ARTOURA BREAST TISSUE EXPANDER ON (B)(6) 2019, EXPERIENCED LEFT BREAST TISSUE EXPANDER DEFLATION. DURING REVISION ON (B)(6) 2019, IT WAS NOTED THAT THERE WAS A HOLE IN THE EXPANDER WHERE THE 6 O¿CLOCK SUTURE TAB TORE AWAY FROM THE EXPANDER. PER SALES REP, IT WAS NOT THE SURGEON WHO NICKED THE IMPLANT, BUT RATHER, THE TAB TORE OFF THE DEVICE, CAUSING DEFLATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A NEW 850CC ARTOURA BREAST TISSUE EXPANDER.

  Patient problems: No Code Available

  MAUDE report 8717434 ↗
• InjuryMay 31, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH AN ARTOURA BREAST TISSUE EXPANDER 850CC DEVICE THAT DEFLATED AFTER IMPLANTATION. A POSSIBLE TISSUE EXPANDER LEAK WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8659334 ↗
• InjuryJan 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A ARTOURA BREAST TISSUE EXPANDER 850CC AND EXPERIENCED DEFLATION ON THE RIGHT TISSUE EXPANDER. AS A RESULT, THE PATIENT HAD UNDERGONE EXPLANTATION ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8223834 ↗
• InjuryNov 29, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR ARTOURA BREAST TISSUE EXPANDER 850 CC EXPANDER WHICH THE RIGHT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED DURING THE EXAMINATION BY THE DOCTOR. AS A RESULT, PATIENT HAD THE DEVICE EXPLANTED ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8116041 ↗
• InjuryMar 28, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH AN ARTOURA BREAST TISSUE EXPANDER 850CC TISSUE EXPANDER AND EXPERIENCED DEFLATION ON THE RIGHT TISSUE EXPANDER. AS A RESULT, THE PATIENT HAD EXPERIENCED EXPLANTATION ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7378755 ↗

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,