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Natrelle® Style 133 Tissue Expanders with Suture Tabs 133FV-15-TRecalls & reported problems

Allergan, Inc. · NATRELLE 133FV With Sut Tab, 750cc · Class U · Implant

All models of Natrelle Breast Implants (1167) · Natrelle Style 133 Tissue Expanders with Suture Tabs (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
4
Recalls naming it
1

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888628004269), received between Dec 5, 2017 and Dec 16, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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

Device problems

  • Fluid/Blood Leak3
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Failure of Implant3
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryDec 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

    HEALTHCARE PROFESSIONAL REPORTED "THE EXPANDER REPLACED HAD DEFLATED DURING CHEMOTHERAPY." UNKNOWN SIDE. DEVICE EXPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 9474977 ↗
  • InjuryAug 1, 2019Fluid/Blood Leak; Fluid/Blood Leak

    HEALTH PROFESSIONAL REPORTED UNKNOWN SIDE DEVICE "DEVELOPED A LEAK." DEVICE REMAINS IMPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 8851888 ↗
  • InjuryDec 6, 2018Fluid/Blood Leak; Fluid/Blood Leak

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION OF TISSUE EXPANDER. PATIENT TOLD PHYSICIAN " IT WAS DEFLATING FOR THE PAST COUPLE WEEKS." DEVICE WAS EXPLANTED.

    Patient problems: Failure of Implant

    MAUDE report 8140199 ↗
  • InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    COMPANY REPRESENTATIVE REPORTED ON BEHALF OF A HEALTH PROFESSIONAL "LEFT BREAST PAIN AND IT WAS MORE SWOLLEN", "BREAST IS STILL RED", AND "BREAST INFECTION ". THE DEVICE REMAINS IMPLANTED.

    Patient problems: Unspecified Infection

    MAUDE report 7082738 ↗

Other Expander, Skin, Inflatable devices

All Expander, Skin, Inflatable devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page