MENTOR Tissue Expander 3504313MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00081317002499), received between Jul 29, 2020 and Jul 29, 2020 — 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.

• MalfunctionJul 29, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 100CC MENTOR TISSUE EXPANDER HAD A HOLE WHEN REMOVED FROM THE BOX FOR A BREAST RECONSTRUCTION. AIR WAS NOTED INSIDE THE EXPANDER UPON OPENING THE DEVICE. IT WAS FLATTENED AND PLACED AND BEGAN FILLING WITH SOME AIR AGAIN. IT WAS REMOVED, L TESTED UNDER SALINE, AND A HOLE WAS DISCOVERED. THERE WERE NO PATIENT CONSEQUENCES NOTED.

  Patient problems: No Patient Involvement

  MAUDE report 10341081 ↗