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

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10888628044180), received between Feb 12, 2020 and Jul 14, 2026 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Contamination

  Healthcare professional, through sales representative, reported "a hair was in one of the products upon opening it". The device was not implanted. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25813146 ↗
• InjurySep 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED "RUPTURED TISSUE EXPANDER". THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22938154 ↗
• InjuryJun 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22190070 ↗
• InjuryMay 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED "NOTICED A SMALL HOLE, LOOKS LIKE IT SEPARATED FROM THE SEAM". LATER HEALTHCARE PROFESSIONAL REPORTED "TISSUE EXPANDER DEFLATED SPONTANEOUSLY DURING POST-OPERATIVE PERIOD AFTER BEING INFLATED IN OPERATING ROOM AT TIME OF SURGERY". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 22015268 ↗
• InjuryApr 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  COMPANY REPRESENTATIVE REPORTED VIA A HEALTHCARE PROVIDER THAT THE HEALTHCARE PROVIDER "EXPLANTED A TISSUE EXPANDER TODAY FOR A UNKNOWN SIDE AND THE "MAGNET DETACHED OUT OF THE BACK AND WAS FLOATING IN THE EXPANDER". THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16819938 ↗
• InjuryApr 4, 2023Device Handling Problem; Device Handling Problem

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "RUPTURE/DEFLATION" - NOT RELATED TO THE DEVICE AND "PHYSICIAN DAMAGED WHILE IMPLANTING¿, "TISSUE EXPANDER WAS PIERCED PRIOR TO IMPLANTATION". THE DEVICE WAS NOT IMPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16675066 ↗
• InjuryOct 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "DEFLATION OF TE." DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 15601726 ↗
• InjuryFeb 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: Failure of Implant

  MAUDE report 13529732 ↗
• InjuryDec 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED "DEFECTIVE TISSUE EXPANDER", "FLUID SEEMED TO BE COMING OUT AND EXPANDER SIDE FLAT", "EXPANDER REMOVED & REPLACED ¿ LINEAR TEAR IN EXPANDER." DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12919922 ↗
• MalfunctionNov 25, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  HEALTHCARE PROFESSIONAL REPORTED "THERE ARE TWO SMALL PIECES OF DEBRIS WITHIN THE SHELL". DEVICE WAS NOT IMPLANTED.

  Patient problems: No Patient Involvement

  MAUDE report 10906564 ↗
• InjuryOct 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10714275 ↗
• MalfunctionOct 5, 2020Break; Break

  HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE "TE THAT LEAKED ON THE TABLE ". DEVICE WAS NOT IMPLANTED.

  Patient problems: No Information

  MAUDE report 10627211 ↗
• InjuryApr 24, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  HEALTHCARE PROFESSIONAL REPORTED THAT WHEN THEY "OPENED THE EXPANDER THEY NOTED SOMETHING ON IT SO THEY USED THE SECOND ONE OF THE SAME SIZE. AT FIRST LOOK IT SEEMS TO BE INK, BUT WHEN TOUCHED IT, IT MOVED SO IT SEEMS TO BE LENT OR STRAND OF FABRIC." DEVICE WAS NOT IMPLANTED.

  Patient problems: No Patient Involvement

  MAUDE report 9997218 ↗
• InjuryApr 21, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  HEALTHCARE PROFESSIONAL REPORTED "SMALL PIECE OF A METALLIC FOREIGN BODY ON THE INFERIOR ASPECT OF THE TISSUE EXPANDER JUST OFF FROM MIDLINE" AND "ANOTHER FOREIGN BODY NOTED WHICH WAS CLEAR AND HAD A BRISTLE-LIKE FILAMENTOUS APPEARANCE" WITH A "STATIC CHARGE" ON A TISSUE EXPANDER THAT WAS NOT IMPLANTED. PATIENT CONTACT DID NOT OCCUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9981125 ↗
• InjuryApr 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

  COMPANY REPRESENTATIVE REPORTED A RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9975881 ↗
• InjuryApr 7, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED "DEFLATION OBSERVED DURING IMPLANT SURGERY" AND "SUSPECTED NEEDLE INJURY". THE DEVICE WAS NOT IMPLANTED. SURGERY WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933617 ↗
• InjuryFeb 13, 2020Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE" OF A TISSUE EXPANDER. DEVICE STATUS REMAINS UNCONFIRMED.

  Patient problems: Failure of Implant

  MAUDE report 9705766 ↗
• InjuryFeb 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "RUPTURE" OF A TISSUE EXPANDER. DEVICE STATUS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 9700951 ↗