Natrelle 133 Plus Tissue Expanders 133P-SX-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888628010468), received between Aug 17, 2018 and Aug 17, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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-2456-2019 · 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.

• MalfunctionAug 17, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  HEALTHCARE PROFESSIONAL REPORTED A DEVICE THAT HAD "DEBRIS ON IT" WHEN THE BOX WAS OPENED. THE DEVICE WAS NOT USED. SURGERY WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 7792727 ↗