Natrelle INSPIRA Breast Implants TRF-325Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10888628008281), received between Feb 14, 2020 and Jun 4, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Device Appears to Trigger Rejection

  PATIENT REPORTED "CAPSULAR CONTRACTURE", BAKER GRADE UNKNOWN. THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 25398876 ↗
• InjuryJul 25, 2024Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED DEVICE RUPTURE. THE DEVICE HAS BEEN EXPLANTED. THIS RECORD RELATES TO AN UNKNOWN SIDE.

  Patient problems: Failure of Implant

  MAUDE report 19826172 ↗
• InjuryMay 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 17030831 ↗
• InjuryMay 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 17026410 ↗
• InjurySep 27, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED LEFT-SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15491774 ↗
• InjurySep 27, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT-SIDE CAPSULAR CONTRACTURE BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 15491183 ↗
• InjuryMay 7, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE "SHOOTING PAIN, HARDNESS, AND TEXTURED TO SMOOTH IMPLANT EXCHANGE DUE TO THE CONCERNS OF THE PRODUCT". HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND TEXTURED TO SMOOTH IMPLANT EXCHANGE DUE TO THE CONCERNS OF THE PRODUCT. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14315694 ↗
• InjuryMay 4, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE SHOOTING PAIN, HARDNESS, AND IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND TEXTURED TO SMOOTH IMPLANT EXCHANGE DUE TO THE CONCERNS OF THE PRODUCT. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14283290 ↗
• InjuryFeb 25, 2022Material Rupture; Material Rupture

  PHYSICIAN REPORTED A RIGHT SIDE RUPTURE. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 13603454 ↗
• InjuryJun 14, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 11996092 ↗
• InjuryFeb 22, 2021Material Rupture; Material Rupture

  PATIENT REPORTED DEVICE WAS EXPLANTED DUE TO RUPTURE AFTER 2 WEEKS OF IMPLANTATION. LEFT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 11359107 ↗
• InjuryFeb 19, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 11355493 ↗
• InjuryFeb 14, 2020Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE IMPLANT RUPTURE. THE DEVICE WAS EXPLANTED,

  Patient problems: Failure of Implant

  MAUDE report 9711154 ↗

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-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-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-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-