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

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10888628004504), received between Sep 22, 2017 and Jun 10, 2019 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2019Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8684770 ↗
• InjuryFeb 12, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  HEALTHCARE PROFESSIONAL REPORTED "CRYSTALIZED GEL ON THE OUTSIDE OF THE TISSUE EXPANDER" AND "BUBBLES". DEVICE WAS NOT IMPLANTED, AND SURGERY WAS SUCCESSFULLY COMPLETED WITH A BACK UP DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 8334087 ↗
• InjuryAug 27, 2018Fluid/Blood Leak; Fluid/Blood Leak

  HEALTH PROFESSIONAL REPORTED LEFT SIDE DEVICE "HAD A SLIT IN IT." THE EXPANDER WAS IMPLANTED FOR OVER A YEAR. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 7820075 ↗
• MalfunctionJun 27, 2018Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED A DEFLATION OF A TISSUE EXPANDER. THE EXPANSION PROCESS WAS COMPLETED. DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR AN UNKNOWN SIDE.

  Patient problems: Failure of Implant

  MAUDE report 7641975 ↗
• InjuryMay 14, 2018Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 7510890 ↗
• MalfunctionApr 12, 2018Break; Break

  HEALTHCARE PROFESSIONAL REPORTED A "PINHOLE" IN A TISSUE EXPANDER. DEVICE MADE CONTACT WITH THE PATIENT. DEVICE WAS NOT IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7427256 ↗
• InjuryFeb 28, 2018Fluid/Blood Leak; Fluid/Blood Leak

  PATIENT REPORTED A LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 7302884 ↗
• InjuryFeb 26, 2018Fluid/Blood Leak; Fluid/Blood Leak

  PATIENT REPORTED A RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 7297201 ↗
• InjurySep 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE INFECTION. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 6886196 ↗