MENTOR Tissue Expander 3505301MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00081317002543), received between Jan 13, 2023 and Jan 13, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR TISSUE EXPANDER, 025CC PROSTHESIS EXPERIENCED DEFLATION POST PROCEDURE. THE REPORT STATED THAT THE PATIENTS WAS PREPARED FOR AN OPERATION ON HER FOREHEAD IN A MOSCOW CLINIC, A NEOPLASM, AT THE BEGINNING OF THE OPERATION IT WAS FOUND THAT THE EXPANDERS WERE DEFECTIVE. NO ADVERSE EVENT, OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162170 ↗