Natrelle INSPIRA Breast Implants SRF-240Recalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 10888628007253), received between May 10, 2019 and Sep 30, 2026 — classified as 103 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (81 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 25 most recent of 104 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture, Baker grade unknown, and exchange". Later, healthcare professional reported "capsular contracture Baker grade III". This record is for the left side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50948921 ↗
• InjurySep 29, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture, Baker grade unknown, and exchange". Later, healthcare professional reported "capsular contracture Baker grade III". This record is for the right side. The device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50936160 ↗
• InjurySep 28, 2026Device Appears to Trigger Rejection

  Patient problems: Capsular Contracture

  MAUDE report 50926115 ↗
• InjurySep 28, 2026Device Appears to Trigger Rejection

  Healthcare professional reported capsular contracture baker grade III/IV. this record is for the left side. Device was explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50912012 ↗
• InjuryAug 20, 2026Device Appears to Trigger Rejection

  Healthcare professional reported "capsular contracture, Baker grade III; Accolade prescribed". This record is for the left side. The device remains implanted.

  Patient problems: Capsular Contracture

  MAUDE report 50356558 ↗
• InjuryAug 17, 2026Device Appears to Trigger Rejection

  The device has been explanted.

  Patient problems: Capsular Contracture

  MAUDE report 50286442 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED "POTENTIAL NIPPLE DEATH". THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE WAS EXPLANTED.

  Patient problems: Ischemia

  MAUDE report 24714954 ↗
• InjuryNov 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED BUT NOT REPLACED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23584131 ↗
• InjuryNov 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" VIA THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED BUT NOT REPLACED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23557033 ↗
• InjurySep 27, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 23163371 ↗
• InjurySep 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 23009932 ↗
• InjuryAug 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED " CAPSULAR CONTRACTURE WITH UNKNOWN BAKER GRADE" VIA "MAMMOGRAM". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THIS RECORD IS FOR THE "LEFT" SIDE. THE DEVICE WAS EXPLANTED AND REPLACED

  Patient problems: Capsular Contracture

  MAUDE report 22833924 ↗
• InjuryAug 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN" VIA "MAMMOGRAM". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE IV". THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22811647 ↗
• InjuryAug 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22756054 ↗
• InjuryJul 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE III". DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22652968 ↗
• InjuryJun 26, 2025Device Appears to Trigger Rejection; Material Rupture; Device Appears to Trigger Rejection; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22338003 ↗
• InjuryJun 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED VIA NBIR LEFT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 22236101 ↗
• InjuryJun 2, 2025Device Appears to Trigger Rejection; Malposition of Device; Device Appears to Trigger Rejection; Malposition of Device

  PATIENT REPORTED "PAIN AND ITCHING, IMPLANTS WERE NOT IN PLACE AND LOOKED WEIRD ¿CONE SHAPED", ALLERGIC TO THE IMPLANTS. HEALTHCARE PROFESSIONAL LATER REPORTED "DESIRE FOR SILICONE BREAST IMPLANTS, BAKER GRADE 4 CAPSULAR CONTRACTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22125117 ↗
• InjuryMay 30, 2025Device Appears to Trigger Rejection; Malposition of Device; Device Appears to Trigger Rejection; Malposition of Device

  PATIENT REPORTED PAIN AND ITCHING, IMPLANTS WERE NOT IN PLACE AND LOOKED WEIRD ¿CONE SHAPED" AND ALLERGIC TO THE IMPLANTS. HEALTHCARE PROFESSIONAL LATER REPORTED CAPSULAR CONTRACTURE, BAKER GRADE IV. THIS RECORD IS FOR THE LEFT SIDE. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22120140 ↗
• InjuryMay 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE IV. HEALTHCARE PROFESSIONAL LATER REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III/IV AND A FOLDED PORTION IN THE SUPERIOR POLE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND NOT REPLACED. IS UNKNOWN IF THE DEVICE WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 22097561 ↗
• InjuryMay 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22023979 ↗
• InjuryMay 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 22020626 ↗
• InjuryMay 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE" BAKER GRADE IV. THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 22015281 ↗
• InjuryMay 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 21998558 ↗
• InjuryMay 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 21973291 ↗

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-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-