Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MV-14-TRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10888628004436), received between Oct 26, 2017 and Oct 9, 2020 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTH PROFESSIONAL REPORTED A RIGHT SIDE "500CC AIR"; USE ERROR DURING IMPLANT PROCEDURE. IT IS UNKNOWN IF THE DEVICE HAS BEEN EXPLANTED OR REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10656336 ↗
• InjuryOct 9, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTH PROFESSIONAL REPORTED A LEFT SIDE "500CC AIR"; USE ERROR DURING IMPLANT PROCEDURE. PLACEMENT OF DEVICE IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 10656275 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED AN UNKNOWN SIDE FOR A TISSUE EXPANDER "FEELING SICK IN MAY, SEVERE FATIGUE. NAUSEA I VOMITING. HOT/COLD SPELLS, TEMPERATURES, LOSS OF APPETITE, OVERALL FEELING VERY BAD," "RECEIVE LAB WORK MULTIPLE TIMES, ALL SHOWING I HAD AN INFECTION," "WAS DIAGNOSED WITH SEVERE SEPSIS, SEPTIC SHOCK, AND WAS TAKEN TO SURGERY FOR IMMEDIATE REMOVAL OF MY IMPLANTS AND EXPANDERS." THIS RECORD WILL BE FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 9889764 ↗
• InjuryOct 28, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN WITH A TISSUE EXPANDER. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9244535 ↗
• InjuryOct 25, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9239136 ↗
• MalfunctionMar 29, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  HEALTHCARE PROFESSIONAL REPORTED "PLASTIC SEEMS WET, AND SOMETHING BROWNISH IS ON THE INSIDE AS WELL." DEVICE WAS NOT IMPLANTED.

  Patient problems: No Patient Involvement

  MAUDE report 8466589 ↗
• MalfunctionNov 29, 2018Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  HEALTH PROFESSIONAL REPORTED UNKNOWN SIDE "LEAKING TISSUE EXPANDER" DURING SURGERY, WHICH WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8114932 ↗
• InjuryOct 30, 2018Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROVIDER REPORTED RIGHT SIDE "RUPTURED" AND CAPSULAR CONTRACTURE BAKER GRADE II. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8021178 ↗
• MalfunctionAug 23, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HEALTHCARE PROFESSIONAL REPORTED "PRODUCT WAS PUNCTURED WHILE PLACING IN THE PATIENT." THE DEVICE WAS NOT IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7810435 ↗
• MalfunctionJul 27, 2018Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method

  DEVICE WAS IMPLANTED FOR MORE THAN 6 MONTHS.

  Patient problems: Failure of Implant

  MAUDE report 7725692 ↗
• InjuryDec 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE "INFECTION." THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 7133941 ↗
• InjuryDec 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE "INFECTION." THE DEVICE HAS BEEN EXPLANTED AND DISCARDED AFTER SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 7133473 ↗
• InjuryOct 26, 2017Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. THE DEVICE WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 6980476 ↗