MENTOR Tissue Expander 3504315MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00081317002512), received between Oct 23, 2019 and Mar 11, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Rupture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 300CC MENTOR TISSUE EXPANDER AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED TISSUE EXPANDER ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement; Insufficient Information

  MAUDE report 11467817 ↗
• InjuryFeb 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 300CC MENTOR TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION AND CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN POST PROCEDURE. PATIENT EXPERIENCED SCAR CONTRACTION. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2020.

  Patient problems: Capsular Contracture; Insufficient Information; No Code Available

  MAUDE report 9772431 ↗
• InjuryOct 23, 2019Off-Label Use; Material Rupture; Use of Device Problem; Off-Label Use; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD HISPANIC FEMALE WHO HAD A 300CC MENTOR TISSUE EXPANDER PLACED IN AN UNKNOWN TYPE OF PROCEDURE EXPERIENCED DEFLATION OF THE DEVICE ON THE LEFT SIDE POST PROCEDURE. AS A RESULT, THE DEVICE WAS REPLACED WITH A 400CC MENTOR TISSUE EXPANDER ON (B)(6) 2018. NO ADDITIONAL INFORMATION REGARDING THE NATURE OF THIS EVENT IS AVAILABLE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE IN THE FUTURE, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 9227107 ↗