Natrelle 133S Tissue Expanders 133S-FX-12-TRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888628044029), received between Mar 27, 2021 and Sep 21, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Fluid/Blood Leak

  Healthcare professional, through company representative, reported: "tissue expander was not expanding in office. We removed the expander and found there was a small hole on the posterior side, causing it to leak". This record is for an unknown-side device. The device was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838932 ↗
• InjuryJul 27, 2026Difficult to Open or Remove Packaging Material

  Healthcare professional, through sales representative, reported "defect where it was stuck to itself". The device was not implanted. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50038374 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "PERI-IMPLANT INFECTION". THE DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21678179 ↗
• InjuryFeb 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL VIA REGULATORY AGENCY REPORTED BILATERAL BREAST TISSUE EXPANDERS PLACED (B)(6) 2022. UPON COMPLETION OF EXPANSION PROCESS AND WHILE WAITING ON SECOND STAGE RECONSTRUCTION, RIGHT TISSUE EXPANDER SPONTANEOUSLY DEFLATED. PATIENT RETURNED TO OR (B)(6) 2023 TO REMOVE AND REPLACE RIGHT EXPANDER DUE TO RETRACTING OF SKIN. LINEAR DEFECT NOTED IN POSTERIOR, LATERAL SEAM OF EXPANDER, APPROXIMATELY 1 CM IN LENGTH. WHEN LOOKING AT THE ANTERIOR SURFACE OF THE TISSUE EXPANDER, DEFECT WAS TO THE LEFT OF THE SUPERIOR TAB. NO OTHER DEFECTS NOTED WITHIN THE TISSUE EXPANDER UPON EXAMINATION. EVENT HAS BEEN CAPTURED AS DEFLATION. THIS RECORD IS FOR RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16399516 ↗
• InjuryJan 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  COMPANY REP REPORTED VIA PHYSICIAN RIGHT SIDE "TISSUE EXPANDER WAS DEFLATED". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant; Seroma

  MAUDE report 16098684 ↗
• InjuryFeb 18, 2022Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE INFECTION (UNKNOWN ONSET) AND EXPOSURE. "PATIENT DID NOT HEAL PROPERLY AFTER MASTECTOMY AND DEVELOPED OPEN WOUND WITH INFECTION AND EXPOSURE OF TISSUE EXPANDER." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 13564182 ↗
• InjuryJan 11, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "EXTRUSION". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Erosion

  MAUDE report 13232352 ↗
• InjuryMar 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE INFECTION. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 11580014 ↗