ARTOURA Breast Tissue Expander TEXP150RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00081317009504), received between Aug 29, 2018 and Jan 9, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Material Rupture” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 18, 2026Class IIOpen, Classified

   Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

   Z-1685-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2026Material Rupture; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROTHESIS IMPLANTATION WITH A 750CC ARTOURA BREAST TISSUE EXPANDER ON AN UNSPECIFIED BREAST SIDE. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BREAST IMPLANT SLOW LEAK. IT WAS ALSO NOTED DURING THE SURGERY THAT THERE WAS A SILICONE FLAW AT THE ATTACHMENT OF THE REINFORCED EDGE NEAR THE LATERAL TAB. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24026644 ↗
• InjuryDec 11, 2025Material Rupture; Connection Problem; Material Rupture; Connection Problem

  IT WAS REPORTED THAT A PATIENT WITH ARTOURA BREAST TISSUE EXPANDERS EXPERIENCED SEROMA AND DEFLATION (SIDE UNKNOWN) POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. UPON EXPLANTATION ON AN UNSPECIFIED DATE, IT WAS DISCOVERED THE INJECTION PORT WAS DEFECTIVE.

  Patient problems: Seroma

  MAUDE report 23785475 ↗
• InjuryFeb 18, 2021Material 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 750CC DEVICE THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST TISSUE EXPANDER WAS OBSERVED DURING A REMOVAL SURGERY ON (B)(6) 2021. A LEAK WAS OBSERVED ON THE SEAM OF THE DEVICE AS WELL AS SOME FLUID BUILDUP ON THE OUTSIDE OF THE DEVICE. AS A RESULT, THE REMOVED DEVICE WAS REPLACED WITH ANOTHER ARTOURA BREAST TISSUE EXPANDER 750CC DEVICE ON THE SAME DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11346681 ↗
• InjuryNov 6, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH ARTOURA BREAST TISSUE EXPANDER 750CC 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 9286466 ↗
• InjuryJun 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 750CC ARTOURA BREAST TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, REPLACEMENT WITH A 700CC MENTOR MEMORYGEL BREAST IMPLANT WAS PERFORMED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8694133 ↗
• InjuryFeb 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN UNKNOWN RECONSTRUCTIVE BREAST SURGERY WITH MENTOR ARTOURA BREAST TISSUE EXPANDER 750CC TISSUE EXPANDER WHICH THE RIGHT SIDE DEFLATED AFTER IMPLANTATION. AS A RESULT PATIENT HAD THE DEVICE REMOVED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8371017 ↗
• InjuryAug 29, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR ARTOURA BREAST TISSUE EXPANDER 750CC DEVICE THAT DEFLATED AFTER IMPLANTATION. THE DOCTOR EXPLANTED THE DEVICE ON (B)(6) 2018 AND NOTICED LEAKING FROM THE SEAMS.

  Patient problems: No Code Available

  MAUDE report 7831182 ↗