ARTOURA Breast Tissue Expander TEXP140RUHRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00081317009573), received between Mar 7, 2018 and Aug 8, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Material Rupture” (6 reports).

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

• InjuryAug 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 42-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH AN ARTOURA BREAST TISSUE EXPANDER 850CC DEVICE THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST TISSUE EXPANDER WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15189097 ↗
• InjuryOct 15, 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 WHO UNDERWENT BREAST RECONSTRUCTION PRIMARY PROCEDURE WITH ARTOURA BREAST TISSUE EXPANDER 850CC ON THE LEFT BREAST IMPLANT AND EXPERIENCED THE ADVERSE EVENTS. SHE PRESENTED WITH BREAST TISSUE ATROPHY/CHEST WALL DEFORMITY, WHICH REQUIRED FLAP RECONSTRUCTION WITH TISSUE EXPANDER INSERTION. IN ADDITION, SHE PRESENTED WITH NECROSIS, WHICH REQUIRED FLAP RECONSTRUCTION WITH TISSUE EXPANDER INSERTION. SHE ALSO PRESENTED WITH BREAST PAIN, WHICH REQUIRED MEDICATION. FINALLY, SHE PRESENTED WITH BAKER III CAPSULAR CONTRACTION, WHICH REQUIRED CAPSULOTOMY TISSUE EXPANDER REMOVAL WITH DEVICE REPLACEMENT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2018.

  Patient problems: Capsular Contracture; Deformity/ Disfigurement; Necrosis; No Code Available; Post Operative Wound Infection

  MAUDE report 10686383 ↗
• InjuryDec 26, 2018Material Rupture; Material Rupture

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

  Patient problems: No Code Available

  MAUDE report 8196699 ↗
• InjuryDec 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE HAD AN 850CC ARTOURA BREAST TISSUE EXPANDER IMPLANTED AND THAT THE TISSUE EXPANDER FAILED. THIS IS INDICATIVE OF DEFLATION. THE DEVICE WAS EXPLANTED ON (B)(6) 2018. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS MADE AVAILABLE IN THE FUTURE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 8186496 ↗
• InjuryOct 22, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR ARTOURA BREAST TISSUE EXPANDER 850CC DEVICE THAT DEFLATED AFTER IMPLANTATION. DURING A VISIT TO THE DOCTOR¿S OFFICE, IT WAS DISCOVERED THAT THE DEVICE IN THE PATIENT¿S RIGHT BREAST HAD COLLAPSED. AS A RESULT, THE PATIENT WILL UNDERGO EXPLANTATION ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7993645 ↗
• InjuryMar 28, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH ARTOURA ROUND, ULTRA HIGH PROFILE 850CC BREAST TISSUE EXPENDER, WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH NON-MENTOR TISSUE EXPENDER CATALOG: 5CX-615, SERIAL NUMBER: (B)(4) ON (B)(6) 2017.

  Patient problems: No Code Available

  MAUDE report 7379068 ↗
• InjuryMar 7, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR ARTOURA BREAST TISSUE EXPANDER 850CC THAT DEFLATED AFTER IMPLANTATION. THE TISSUE EXPANDER STOPPED FILLING AND THERE WAS A TEAR ON THE SEAM OF THE DEVICE. THE PATIENT FULLY RECOVERED AND SHE EXPERIENCED NO ACCOMPANYING SYMPTOMS. AS A RESULT OF THE DEFLATION, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR ARTOURA BREAST TISSUE EXPANDER 850CC ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7322615 ↗