ARTOURA Breast Tissue Expander SMXP140RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00081317024330), received between Apr 4, 2018 and Mar 10, 2023 — classified as 29 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (24 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 600CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON AN UNKNOWN SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING EXPLANTATION SURGERY. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16526296 ↗
• InjuryFeb 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 600CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA AN OFFICE EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13417157 ↗
• InjuryJul 15, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH 600CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED RIGHT-SIDED EXPANDER DEFLATION POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN UNSPECIFIED BREAST IMPLANT ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12171607 ↗
• MalfunctionApr 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 600CC ARTOURA BREAST TISSUE EXPANDER WAS FOUND TO BE DEFLATED OUT OF THE BOX. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11721048 ↗
• InjuryMar 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 600CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED POSTOPERATIVE DEFLATION (SIDE UNKNOWN). THE DIAGNOSIS WAS CONFIRMED BY THE PATIENT¿S SURGEON. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A AN UNSPECIFIED TISSUE EXPANDER ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11522307 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH AN ARTOURA BREAST TISSUE EXPANDER 600CC AND SUFFERED FROM A BREAST INVASIVE DUCTAL CARCINOMA ON THE RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 560CC ON (B)(6) 2020.

  Patient problems: Cancer; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11233109 ↗
• InjuryDec 5, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH AN ARTOURA BREAST TISSUE EXPANDER 600CC DEVICE THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST TISSUE EXPANDER WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 10954183 ↗
• InjuryDec 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH AN ARTOURA BREAST TISSUE EXPANDER 600CC AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2020. PATIENT CONDITION WAS IMPROVED POST-EXPLANTATION.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 10945502 ↗
• MalfunctionNov 19, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A 600CC ARTOURA BREAST TISSUE EXPANDER WAS BEING USED FOR A PRIMARY BREAST RECONSTRUCTION, AND THE DEVICE COULD NOT BE EXPANDED INTRAOPERATIVELY (SIDE UNKNOWN). AS A RESULT, THE IMPLANTATION SURGERY WAS COMPLETED WITH AN UNSPECIFIED TISSUE EXPANDER. NO PATIENT CONSEQUENCES OR PROCEDURAL DELAYS WERE REPORTED. AT THE TIME OF THIS REPORT, THERE IS NO EVIDENCE OF A NEED FOR ADDITIONAL SURGICAL INTERVENTION. A HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAS BEEN FULLY RECOVERED. HOWEVER, IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10872220 ↗
• InjuryNov 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH ARTOURA BREAST TISSUE EXPANDER 600CC (LEFT) AND AN UNSPECIFIED MENTOR TISSUE EXPANDER (RIGHT) AND EXPERIENCED A DEFLATION ON THE LEFT SIDE AND A SEROMA ON THE RIGHT SIDE POST-OPERATIVELY. THE RIGHT SIDE REQUIRED SURGICAL INTERVENTION AND THE PATIENT HAD A DRAIN PLACED TO DRAIN THE FLUID. THE PATIENT UNDERWENT EXPLANTATION OF THE LEFT SIDE ON (B)(6) 2020. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

  Patient problems: No Code Available

  MAUDE report 10856976 ↗
• MalfunctionOct 13, 2020Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 600CC MENTOR ARTOURA BREAST TISSUE EXPANDER SECONDARY TO INTRADUCTAL CARCINOMA OF THE LEFT BREAST HAD THE DEVICE IMPLANTED FOR LONGER THAN SIX MONTHS. PER THE INSTRUCTIONS FOR USE, THESE DEVICES ARE NOT TO REMAIN IMPLANTED FOR LONGER THAN SIX MONTHS, MEANING THE DEVICE WAS USED OFF-LABEL. THE EXPANDER WAS PLACED ON (B)(6) 2019, AND ON (B)(6) 2020, WAS EXPLANTED AND REPLACED WITH A PERMANENT IMPLANT. WITH THE INFORMATION AVAILABLE AT THE TIME OF THIS REPORT, THERE IS NOTHING TO SUGGEST THAT THERE WERE ANY DEVICE ISSUES OR PATIENT CONSEQUENCES. THIS EVENT IS BEING CONSERVATIVELY REPORTED TO CAPTURE THE OFF-LABEL USE OF THE DEVICE.

  Patient problems: No Code Available

  MAUDE report 10672976 ↗
• InjuryOct 10, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A REVISION BREAST RECONSTRUCTION WITH A 600CC ARTOURA BREAST TISSUE EXPANDER PROSTHESIS AND EXPERIENCED POSTOPERATIVE LEFT-SIDED DEFLATION. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AT THE TIME OF EVENT, THE PATIENT¿S SURGEON COMPLETED TWO FILLS INTO THE EXPANDER, AND THE PATIENT WAS LESS THAN TWO MONTHS IN FOR THE EXPANSION PROCESS. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10659965 ↗
• InjuryOct 6, 2020Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH AN ARTOURA BREAST TISSUE EXPANDER 600CC AND EXPERIENCED MALIGNANT NEOPLASM ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNSPECIFIED BREAST IMPLANTS ON (B)(6) 2020. THIS DEVICE WAS USED IN AN OFF-LABEL MANNER. PER THE IFU, THIS DEVICE IS NOT INTENDED FOR USE BEYOND SIX MONTHS.

  Patient problems: Cancer; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10635749 ↗
• InjuryAug 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 600CC ARTOURA BREAST TISSUE EXPANDER PROSTHESES AND EXPERIENCED POSTOPERATIVE BILATERAL SOFT TISSUE NECROSIS AND LEFT-SIDED DEFLATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED MENTOR TISSUE EXPANDER FOR THE LEFT SIDE AND SURGICAL INTERVENTION FOR THE RIGHT-SIDED SOFT TISSUE NECROSIS ON (B)(6) 2020. THE PATIENT¿S SURGEON STATED THAT THERE SEEMS TO BE A LEAK NEAR 6 O¿CLOCK SUTURE TAB OF THE LEFT TISSUE EXPANDER. THE DATE OF PROBLEM OBSERVED WAS ESTIMATED BASED OFF OF THE PROVIDED INFORMATION. FOLLOW-UP IS STILL IN PROGRESS. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

  Patient problems: Necrosis; No Code Available

  MAUDE report 10432868 ↗
• InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH TWO 600 CC ARTOURA BREAST TISSUE EXPANDER PROSTHESES AND EXPERIENCED POSTOPERATIVE BILATERAL SOFT TISSUE NECROSIS AND LEFT-SIDED DEFLATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED MENTOR TISSUE EXPANDER FOR THE LEFT SIDE AND SURGICAL INTERVENTION FOR THE RIGHT-SIDED SOFT TISSUE NECROSIS ON (B)(6) 2020. THE PATIENT¿S SURGEON STATED THAT THERE SEEMS TO BE A LEAK NEAR 6 O¿CLOCK SUTURE TAB OF THE LEFT TISSUE EXPANDER. THE DATE OF PROBLEM OBSERVED WAS ESTIMATED BASED OFF OF THE PROVIDED INFORMATION. FOLLOW-UP IS STILL IN PROGRESS. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: Necrosis; No Code Available

  MAUDE report 10432811 ↗
• InjuryApr 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 600CC ARTOURA BREAST TISSUE EXPANDER ON BOTH SIDES AND WAS PRESENTED WITH BILATERAL EXPANDER DEFLATION POSTOPERATIVELY. AS A RESULT, THE EXPANDERS WERE EXPLANTED ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: No Code Available

  MAUDE report 10005632 ↗
• InjuryApr 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 600CC ARTOURA BREAST TISSUE EXPANDER ON BOTH SIDES AND WAS PRESENTED WITH BILATERAL EXPANDER DEFLATION POSTOPERATIVELY. AS A RESULT, THE EXPANDERS WERE EXPLANTED ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: No Code Available

  MAUDE report 10005613 ↗
• InjuryFeb 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH AN ARTOURA BREAST TISSUE EXPANDER 600CC DEVICE THAT DEFLATED AFTER IMPLANTATION. THE PATIENT NOTICED THAT HER LEFT BREAST WAS FLAT. A LEAK IN THE LEFT BREAST TISSUE EXPANDER WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN UNSPECIFIED MENTOR TISSUE EXPANDER ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9709072 ↗
• InjuryDec 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR ARTOURA BREAST TISSUE EXPANDER IMPLANTS WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. AS A RESULT PATIENT HAD THE IMPLANT REMOVED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9481753 ↗
• InjuryDec 8, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 600CC ARTOURA BREAST TISSUE EXPANDER AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION. AS A RESULT, THE PATIENT HAD THE IMPLANT EXPLANTED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9435060 ↗
• InjuryAug 14, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNSPECIFIED PROCEDURE WITH ARTOURA BREAST TISSUE EXPANDER 600CC AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8894797 ↗
• InjuryMay 6, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST SURGERY WITH MENTOR ARTOURA BREAST TISSUE EXPANDER 600CC BREAST IMPLANTS WHICH THERE WAS ISSUE WITH RIGHT SIDE AFTER IMPLANTATION. THE ISSUE WAS FOUND BY THE PHYSICIAN. AS A RESULT PATIENT HAD THE DEVICE REMOVED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8583164 ↗
• InjuryOct 3, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE UNDERWENT BREAST RECONSTRUCTION WITH 600CC ARTOURA BREAST TISSUE EXPANDERS. ON (B)(6) 2018 LEFT SIDED DEFLATION WAS FIRST NOTICED, AND RIGHT SIDED DEFLATION WAS NOTICED ON (B)(6) 2018. AS A RESULT, BILATERAL REPLACEMENT WITH 790CC MENTOR MEMORYGEL BREAST IMPLANTS. (SEE 1645337-2018-05960 FOR CONTRALATERAL PROSTHESIS REPORT).

  Patient problems: No Code Available

  MAUDE report 7930569 ↗
• InjuryOct 3, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE UNDERWENT BREAST RECONSTRUCTION WITH 600CC ARTOURA BREAST TISSUE EXPANDERS. ON (B)(6) 2018 LEFT SIDED DEFLATION WAS FIRST NOTICED, AND RIGHT SIDED DEFLATION WAS NOTICED ON (B)(6) 2018. AS A RESULT, BILATERAL REPLACEMENT WITH 790CC MENTOR MEMORYGEL BREAST IMPLANTS. (SEE 1645337-2018-05961 FOR CONTRALATERAL PROSTHESIS REPORT).

  Patient problems: No Code Available

  MAUDE report 7930546 ↗
• InjuryJun 14, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A ARTOURA BREAST TISSUE EXPANDER 600 CC DEVICE THAT DEFLATED AFTER IMPLANTATION. THE LEFT SIDE DEFLATION WAS OBSERVED BY THE DOCTOR. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR MEMORYGEL BREAST IMPLANT 700 CC GEL BREAST PROSTHESIS ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7603551 ↗

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