Natrelle® Style 133 Tissue Expanders with Suture Tabs 133FV-12-TRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888628004238), received between Oct 20, 2020 and Oct 20, 2020 — classified as 1 injury.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 24, 2019Class IOpen, Classified

   The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

   Z-2457-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

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.

• InjuryOct 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED "I HAD TWO REPLACEMENT IMPLANTS (TISSUE EXPANDERS) AND ONE HAD FAILED. THE PATIENT WAS CONCERNED WITH GETTING LUMPY SORE SPOT. THE RIGHT BREAST IMPLANT IS THE ONLY ONE I HAD FOR ONE YEAR AND IT DEVELOPED AN ENORMOUS SEROMA (80 MLS OF FLUID WAS DRAINED). IT WAS LIKE A SEVERE INFECTION AND THE CULTURES WERE NEGATIVE. THE INFECTION GOT SO BAD AND THE DRAINAGE WAS HORRIBLE STUFF THAT HAD TO REMOVED." THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 10704788 ↗