Natrelle Inspira Cohesive Breast Implants TCX-800Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888628031425), received between Apr 5, 2020 and Dec 23, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (P020056); they may or may not involve this specific model.

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-2453-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2021Material Rupture; Material Rupture

  PATIENT CALLED AND REPORTED A LEFT SIDE RUPTURE, THE LEFT SIDE BREAST WAS VERY LARGE, LEFT SIDE FLUID, AND EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENT¿S CONCERN WITH THE PRODUCT. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant; Seroma

  MAUDE report 13080358 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED EXCHANGE FROM TEXTURED TO SMOOTH BREAST IMPLANTS DUE TO THE PATIENTS CONCERN WITH THE PRODUCT. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED "VERY THIN MILD GRADE I CAPSULE" AND "NORMAL SMALL AMOUNT OF SERIOUS FLUID, BEGIN APPEARING". DEVICE HAS BEEN EXPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

  Patient problems: Seroma

  MAUDE report 11250030 ↗
• InjuryAug 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED AN ENLARGED LYMPH NODE IN HER RIGHT BREAST IMPLANT. DEVICE REMAINS IMPLANTED.

  Patient problems: Swollen Lymph Nodes

  MAUDE report 10375931 ↗
• InjuryApr 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN. ADDITIONALLY, PATIENT REPORTED "INFLAMMATION AND STUFF". HEALTHCARE PROFESSIONAL ADDITIONALLY REPORTED "PAIN/DISCOMFORT"; THESE ISSUES ARE NOT DEVICE RELATED. THE DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Capsular Contracture; Inflammation

  MAUDE report 9928575 ↗
• InjuryApr 5, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN; ADDITIONAL REPORT OF "PAIN AND DISCOMFORT" DUE TO PREVIOUS TREATMENTS, NOT DEVICE RELATED. ADDITIONALLY, PATIENT REPORTED "INFLAMMATION AND STUFF". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture; Inflammation

  MAUDE report 9927064 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020056. One submission often covers many models, so check the product and lot details in each record.

• Z-0701-2020 · Nov 6, 2019 · Terminated
  Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 762
• Z-0700-2020 · Nov 6, 2019 · Terminated
  Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod
• Z-2454-2019 · Jul 24, 2019 · Open, Classified
  Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-