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Natrelle® Style 133 Tissue Expanders 133FX-13Recalls & reported problems

Allergan, Inc. · NATRELLE 133FX-13, 550 cc · Class U · Implant

All models of Natrelle Breast Implants (1167) · Natrelle Style 133 Tissue Expanders (42)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
4
Deaths reported
0
Injuries reported
3
Recalls naming it
1

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888628004009), received between Nov 2, 2017 and Dec 24, 2018 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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-2455-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Break1
  • Fluid/Blood Leak1
  • Improper or Incorrect Procedure or Method1

Patient problems

  • Unspecified Infection2
  • Failure of Implant1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 24, 2018Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

    COMPANY REPRESENTATIVE REPORTED TISSUE EXPANDER "DID NOT FULLY DEFLATE BUT NO HOLES OR LEAKS" PRIOR TO INSERTION, AND ADDITIONALLY HEALTHCARE PROFESSIONAL REPORTED "THEY ACTUALLY HAD TO IMPLANT IT ON THE RIGHT SIDE.¿ DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8193792 ↗
  • InjuryJan 2, 2018Fluid/Blood Leak; Fluid/Blood Leak

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION OF A TISSUE EXPANDER. DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER TISSUE EXPANDER.

    Patient problems: Failure of Implant

    MAUDE report 7158602 ↗
  • InjuryNov 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    HEALTHCARE PROFESSIONAL REPORTED RED BREAST AND INFECTION OF AN UNKNOWN SIDE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

    Patient problems: Unspecified Infection

    MAUDE report 6996970 ↗
  • InjuryNov 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    HEALTHCARE PROFESSIONAL REPORTED RED BREAST AND INFECTION OF AN UNKNOWN SIDE. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

    Patient problems: Unspecified Infection

    MAUDE report 6996968 ↗

Other Expander, Skin, Inflatable devices

All Expander, Skin, Inflatable devices →

Sources and updates

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