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

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888628004122), received between Nov 30, 2017 and Sep 3, 2019 — classified as 5 injuries, 3 malfunctions.

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

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 3, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN AND THE DEVICE BEING IMPLANTED FOR MORE THAN 6 MONTHS. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8958277 ↗
• InjuryApr 9, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8495267 ↗
• MalfunctionFeb 12, 2019Break; Break

  HEALTHCARE PROVIDER REPORTED LEFT SIDE "DURING USE OF TWO TISSUE EXPANDERS FOR THE SAME PATIENT TODAY, THE "LAST 10% OF AIR WOULD NOT COME OUT". DEVICE REMAINS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8332188 ↗
• MalfunctionFeb 12, 2019Break; Break

  HEALTHCARE PROVIDER REPORTED RIGHT SIDE "DURING USE OF TWO TISSUE EXPANDERS FOR THE SAME PATIENT TODAY, THE "LAST 10% OF AIR WOULD NOT COME OUT". DEVICE REMAINS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8330912 ↗
• MalfunctionAug 24, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  HEALTHCARE PROFESSIONAL REPORTED A TISSUE EXPANDER "WOULD NOT FILL PROPERLY," AND, "THE VALVE WAS SEPARATED FROM THE TISSUE EXPANDER POCKET." SURGERY WAS COMPLETED WITH A BACKUP DEVICE. PATIENT CONTACT DID NOT OCCUR.

  Patient problems: No Patient Involvement

  MAUDE report 7812810 ↗
• InjuryMar 27, 2018Fluid/Blood Leak; Fluid/Blood Leak

  HEALTH PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION, "FLUID HAD A DARK BROWN YELLOW APPEARANCE", AND DEVICE WAS IMPLANTED LONGER THAN SIX MONTHS. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 7374868 ↗
• InjuryMar 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  HEALTH PROFESSIONAL REPORTED LEFT SIDE "LOOKED SMALLER AND DEFLATED " AND DEVICE WAS IMPLANTED LONGER THAN 6 MONTHS. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 7351117 ↗
• InjuryNov 30, 2017Break; Break

  COMPANY REPRESENTATIVE REPORTED "PARTIAL SHELL TEAR WAS FOUND" WITH A TISSUE EXPANDER. PATIENT CONTACT WAS NOT MADE. SURGERY WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7073913 ↗