ARTOURA Breast Tissue Expander SMXP140RUHRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00081317024415), received between Apr 18, 2018 and Mar 24, 2021 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT, WHO'S UNDERGONE PRIMARY BREAST RECONSTRUCTION WITH A 850CC ARTOURA BREAST TISSUE EXPANDER ON THE LEFT SIDE, SUFFERED BREAST IMPLANT DEFLATION, POST-PROCEDURE. THE PATIENT HAD SURGERY THE WEEK PRIOR WHERE SHE WAS PLACED FACE DOWN ON HER STOMACH, AND REPORTEDLY BASED ON THE PATIENT'S WEIGHT, THEY THINK THIS MIGHT HAVE CAUSED THE DEFLATION. THE IMPLANT HAD A HOLE AND THE PATIENT ALSO NOTICED THAT IT WAS NOT THE SAME SIZE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND THEN BILATERAL REPLACEMENT ON (B)(6) 2021 WITH THE FOLLOWING DEVICES: (RIGHT) 800CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3508001BC LOT: 9494509 SN: (B)(4) AND (LEFT) 800CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3508001BC LOT: 9410625 SN: (B)(4).

  Patient problems: Crushing Injury

  MAUDE report 11564035 ↗
• InjuryMar 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST RECONSTRUCTION PRIMARY WITH A MENTOR ARTOURA BREAST TISSUE EXPANDER 850CC SALINE PROTHESIS EXPERIENCED SPONTANEOUS LEFT SIDED DEFLATION POST PROCEDURE. PHYSICAL EXAMINATION CONFIRMED DEFLATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: LEFT REPLACED WITH CAT #: SMXP140RUH, SN #: (B)(4), AND RIGHT-SIDE CAT AND SN # IS UNKNOWN ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11554599 ↗
• MalfunctionJan 12, 2021Filling Problem; Filling Problem

  IT WAS REPORTED THAT A 850CC ARTOURA BREAST TISSUE EXPANDER WOULD NOT INFLATE WHEN REMOVED FROM THE BOX PRE-OPERATIVELY. DURING A BREAST RECONSTRUCTION SURGERY, THE PHYSICIAN STATED THAT THE TISSUE EXPANDER WOULD NOT INFLATE TO BE IMPLANTED. NO PATIENT CONSEQUENCE OR PROCEDURAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11157111 ↗
• InjuryDec 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A ARTOURA BREAST TISSUE EXPANDER 850CC AND SUFFERED FROM A DEFLATION OF TISSUE EXPANDER ON THE RIGHT SIDE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2020.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11043575 ↗
• InjuryDec 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION WITH 850CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED LEFT-SIDED EXPANDER DEFLATION POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL EXPLANTATION AND REPLACEMENT WITH LIKE DEVICE, CATALOG # SMXP140RUH, LEFT LOT-SERIAL # (B)(4) ON (B)(6) 2020.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11013737 ↗
• InjuryOct 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 850CC ARTOURA BREAST TISSUE EXPANDER PROSTHESIS (SIDE UNKNOWN) AND EXPERIENCED DEFLATION POSTOPERATIVELY. THE PATIENT UNDERWENT EXPLANTATION OF THE TISSUE EXPANDER ON (B)(6) 2020, AND THE PATIENT'S SURGEON SENT IN A PHOTO OF THE DEVICE TO MENTOR ON THE SAME DAY. THE SURGEON STATED THAT HE WOULD LIKE TO RETURN THE DEVICE. HOWEVER, AT THAT TIME, IT WAS NOT KNOWN WHY THE PATIENT UNDERWENT THE EXPLANTATION SURGERY, AND THE SURGEON WANTED TO SEND BACK THE DEVICE. ON (B)(6) 2020, THE SURGEON REPORTED THAT THE DEVICE WAS DEFLATED, AND UPON EXPLANTATION THE DEVICE WAS FOUND TO HAVE A RENT IN THE LATERAL ASPECT OF THE EXPANDER.

  Patient problems: No Code Available

  MAUDE report 10749260 ↗
• InjuryJun 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST RECONSTRUCTION SURGERY WITH ARTOURA BREAST TISSUE EXPANDER 850CC SALINE BREAST IMPLANTS WHICH THE PATIENT EXPERIENCED BREAST CANCER. AS A RESULT, PATIENT UNDERWENT BILATERAL MASTECTOMY, AND BILATERAL EXCHANGE OF TISSUE EXPANDER TO SALINE IMPLANT AS FOLLOW: LEFT REPLACED WITH CAT#:3502550, SN#:(B)(4), AND RIGHT REPLACED WITH CAT#: 3502550, SN#: (B)(4) ON (B)(6) 2020. THIS REPORT IS FOR THE LEFT SIDE.

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

  MAUDE report 10186849 ↗
• InjuryJun 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST RECONSTRUCTION SURGERY WITH ARTOURA BREAST TISSUE EXPANDER 850CC SALINE BREAST IMPLANTS WHICH THE PATIENT EXPERIENCED BREAST CANCER. AS A RESULT, PATIENT UNDERWENT BILATERAL MASTECTOMY, AND BILATERAL EXCHANGE OF TISSUE EXPANDER TO SALINE IMPLANT AS FOLLOW: LEFT REPLACED WITH CAT#:3502550, SN#:(B)(4), AND RIGHT REPLACED WITH CAT#: 3502550, SN#: (B)(4) ON (B)(6) 2020. THIS REPORT IS FOR THE RIGHT SIDE.

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

  MAUDE report 10186848 ↗
• InjuryApr 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE UNDERWENT BREAST RECONSTRUCTION REVISION WITH 850CC SALINE MENTOR ARTOURA BREAST TISSUE EXPANDERS AND EXPERIENCED DEFLATION ON THE ON THE RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9965619 ↗
• InjuryOct 22, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WITH UNKNOWN AGE AND RACE UNDERWENT UNSPECIFIED BREAST RECONSTRUCTION SURGERY WITH A 850CC ARTOURA BREAST TISSUE EXPANDER AND WAS PRESENTED WITH RIGHT SIDE TISSUE EXPANDER LEAK. AS A RESULT, THE EXPANDER WAS EXPLANTED AND REPLACED WITH SIENTRA BRAND EXPANDER ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9221399 ↗
• InjuryApr 18, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH MENTOR ARTOURA 850CC TISSUE EXPANDERS WHICH THE RIGHT SIDE DEFLATED AFTER IMPLANTATION. AS A RESULT, PATIENT HAD THE DEVICE REMOVED AND REPLACED WITH ANOTHER SMOOTH ARTOURA UHP 850CC TISSUE EXPANDER, SERIAL NUMBER (B)(4) ON (B)(6) 2018. BESIDE THE SURGERY, NO OTHER SYMPTOMS OBSERVED.

  Patient problems: No Code Available

  MAUDE report 7441732 ↗

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