MENTOR Tissue Expander 3504317MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00081317002536), received between Mar 12, 2019 and Dec 22, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE WHO UNDERWENT AN UNSPECIFIED FOREHEAD SURGERY WITH A MENTOR SCALP TISSUE EXPANDER, 500CC IMPLANT EXPERIENCED DEFLATION INTRAOPERATIVELY. IT HAPPENED DURING INSERTING THE IMPLANT ON (B)(6) 2021. ANOTHER IMPLANT WAS USED AND PROCEDURE WENT AS EXPECTED. NO ADVERSE EVENT OR PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13064041 ↗
• InjuryMar 12, 2019Off-Label Use; Material Rupture; Use of Device Problem; Off-Label Use; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH MENTOR TISSUE EXPANDER 500CC EXPANDER WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. AS A RESULT PATIENT HAD THE DEVICE REMOVED AND REPLACED WITH UNKNOWN EXPANDER ON (B)(6) 2019. THE PATIENT DID NOT EXPERIENCE ANY ACCOMPANYING SYMPTOMS, WAS NOT HOSPITALIZED, AND HAS SINCE FULLY RECOVERED.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 8412942 ↗