MENTOR Tissue Expander 3504301MRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00081317002376), received between Mar 25, 2019 and Aug 15, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING IMPLANTATION SURGERY OF A 100CC MENTOR TISSUE EXPANDER PROSTHESIS; A SOLUTION INJECTION TEST WAS PERFORMED. THERE WAS RESISTANCE TO FILL THE DEVICE AND SUBSEQUENT BULGE AND AN INABILITY TO FILL WAS ENCOUNTERED. NO DELAYS, ADVERSE EVENTS, OR PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816174 ↗
• MalfunctionDec 5, 2024Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT A MENTOR TISSUE EXPANDER BEING USED IN A BREAST IMPLANTATION PROCEDURE WAS FOUND TO HAVE A LABELING DISCREPANCY DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855651 ↗
• MalfunctionMay 10, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A MENTOR TISSUE EXPANDER 100CC WAS BEING USED IN A SCALP EXPANSION PROCEDURE. THE SURGEON REPORTED DIFFICULTY INFLATING THE EXPANDER DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGERY WAS CONCLUDED AS THERE WERE NO REPLACEMENT EXPANDERS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288348 ↗
• InjuryNov 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR EXP RECT REMOTE 100CC, TISSUE EXPANDER EXPERIENCED UNKNOWN-SIDED DEFLATION POSTOPERATIVELY. AS, A RESULT, PATIENT UNDERWENT REPLACEMENT WITH CAT#: 3504301M; SN#: (B)(4) ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15717785 ↗
• MalfunctionMar 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH A MENTOR 100CC TISSUE EXPANDER THAT DEFLATED INTRAOPERATIVELY. AS A RESULT, THE DEVICE WAS REPLACED WITH A MENTOR TISSUE EXPANDER 400CC, CATALOG NUMBER 3504303M, SERIAL NUMBER (B)(4), LOT NUMBER 7359417. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8450088 ↗