Natrelle INSPIRA Breast Implants SRX-225Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10888628007444), received between Jun 20, 2019 and Sep 9, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 reports).

4 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50699283 ↗
• InjuryMay 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE III. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 21969606 ↗
• InjuryApr 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 16820046 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "INFECTION" AGAINST RIGHT DEVICE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 15123142 ↗
• InjuryOct 22, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ¿EXPOSED IMPLANT¿. DEVICE HAS BEEN EXPLANTED.

  Patient problems: Foreign Body Reaction

  MAUDE report 12683028 ↗
• InjuryDec 27, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV, "PAINFUL BREAST DEFORMITY BILATERALLY AND DEVICES ARE IN THE SUPERIOR BREAST POSITION". DEVICE WAS EXPLANTED. THIS RECORD IS FOR THE LEFT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 9527399 ↗
• InjuryDec 27, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV, "PAINFUL BREAST DEFORMITY BILATERALLY AND DEVICES ARE IN THE SUPERIOR BREAST POSITION". DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9527167 ↗
• InjuryDec 17, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 9481569 ↗
• InjuryJun 20, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  HEALTH PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV, "POORLY DEFINED INFRAMMARY FOLD WITH A DOUBLE BUBBLE SIGN", AND "POOR COSMETIC RESULT" . DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 8716188 ↗

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-2453-2019 · Jul 24, 2019 · Open, Classified
  Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TR
• 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-