Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MX-13-TRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10888628004481), received between Sep 5, 2017 and Dec 31, 2025 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED ¿HAD THE NATRELLE 133MX-13T TISSUE EXPANDER IN PRIOR TO HER IMPLANTS. SHE HAS WITHIN THE LAST YEAR BEEN DIAGNOSED WITH CHRONIC LYMPHATIC LEUKEMIA¿ AND ¿HAD THE EXPANDERS IN FOR A LITTLE BIT LONGER PERIOD DUE TO AN INFECTION¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED. UNKNOWN IF DEVICE WILL BE RETURNED.

  Patient problems: Unspecified Infection

  MAUDE report 23933103 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  PATIENT REPORTED ¿HAD THE NATRELLE 133MX-13T TISSUE EXPANDER IN PRIOR TO HER IMPLANTS. SHE HAS WITHIN THE LAST YEAR BEEN DIAGNOSED WITH CHRONIC LYMPHATIC LEUKEMIA¿ AND ¿HAD THE EXPANDERS IN FOR A LITTLE BIT LONGER PERIOD DUE TO AN INFECTION¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED. UNKNOWN IF DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 23933058 ↗
• InjuryNov 3, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE CONFIRMED VIA ULTRASOUND. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 18063408 ↗
• InjuryMay 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED A POSSIBLE LEFT SIDE DEFLATION AGAINST A TISSUE EXPANDER. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8634031 ↗
• MalfunctionApr 26, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  HEALTHCARE PROVIDER REPORTED "BROWN SUBSTANCE ON THE EXPANDER WHEN THEY OPENED IT." SURGERY WAS COMPLETED WITH A BACK UP DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 8554418 ↗
• InjuryFeb 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED "DEFLATION." THE DEVICE WAS ADDITIONALLY IMPLANTED FOR MORE THAN 6 MONTHS. DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 8362461 ↗
• InjuryFeb 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "DURING AN EXPANSION TODAY, HE RE-INFLATED A LEFT TISSUE EXPANDER ABOUT 240CC, BUT WHEN HE REMOVED THE NEEDLE FROM THE PORT SITE, IT KEEPS DRIPPING CLEAR FLUID." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8355873 ↗
• MalfunctionFeb 14, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED "WHEN THE SURGEON WAS CLOSING THE POCKET HE ACCIDENTALLY PUNCTURED THE TISSUE EXPANDER AND HAD A TO USE ANOTHER ONE." THE DEVICE WAS NOT IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8338740 ↗
• InjuryJan 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURED" TISSUE EXPANDER WITH A "NEARLY 2 CM CLEAN FRACTURE OF THE SHELL AT THE RIGID POSTERIOR SURFACE." DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8267138 ↗
• InjurySep 17, 2018Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED "HALF OF VOLUME LEAKED OUT OF THE TISSUE EXPANDER OVER A 9 MONTH PERIOD." SIDE UNSPECIFIED. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 7882208 ↗
• InjuryJul 23, 2018Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED A "DEFECTIVE TISSUE EXPANDER" THAT WAS "LEAKING FROM THE BASE PLATE." IT IS UNKNOWN IF THE EVENT WAS NOTICED PRIOR TO IMPLANT SURGERY OR IF IT WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 7710659 ↗
• MalfunctionMay 25, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  HEALTHCARE PROFESSIONAL REPORTED LABELING ERROR CONCERNING THE BARCODE FOR THE LABEL. THE LABEL COULD NOT BE SCANNED PROPERLY. DEVICE WAS USED AND IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7545996 ↗
• InjuryFeb 26, 2018Fluid/Blood Leak; Fluid/Blood Leak

  HEALTH PROFESSIONAL REPORTED RIGHT SIDE TISSUE EXPANDER DEFLATION. SURGERY WAS COMPLETED WITH A BACK UP DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 7297055 ↗
• MalfunctionOct 10, 2017Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED "THE DEVICE WAS PLACED, BEGAN FILLING IT AT THE TIME OF MASTECTOMY AND NOTICED IT WAS ALREADY LEAKING." SURGERY WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 6936191 ↗
• InjurySep 5, 2017No Apparent Adverse Event; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED "BILATERAL INFECTION". THE DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE, SEE MFR# 9617229-2017-02107 FOR THE LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 6841646 ↗
• InjurySep 5, 2017No Apparent Adverse Event; No Apparent Adverse Event

  HEALTHCARE PROFESSIONAL REPORTED "BILATERAL INFECTION". THE DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE, SEE MFR# 9617229-2017-02108 FOR THE RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 6841641 ↗