NATRELLE Saline-Filled Breast Implants 468-230Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10888628001091), received between Apr 4, 2018 and Jul 27, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).

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

4 other recalls cover devices cleared under the same FDA submission (P990074); 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-2451-2019 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient did not report an event. Later patient reported "slight rippling on the side, "implant was past shelf life", and "removal of a textured device". Later healthcare professional reported "exchange due to implant being textured and age of implant". Later healthcare professional reported "slight rippling". This record is for the right side. Device was explanted.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50024469 ↗
• InjuryJul 13, 2026Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED "DEFLATED IMPLANT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25795761 ↗
• InjuryJun 15, 2026Fluid/Blood Leak

  PATIENT REPORTED ¿POSSIBLE DEFLATION¿, ¿ITCHING¿, ¿PAIN¿, ¿LUMP OR MASS¿, ¿IMPLANT FOLDING¿, ¿BEEN SICK¿ AND ¿HAVING ISSUES WITH LYMPH NODES¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25508368 ↗
• InjuryMay 26, 2026Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED ¿DEFLATION¿. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 25284613 ↗
• InjuryFeb 10, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24309914 ↗
• InjuryFeb 10, 2026Device Appears to Trigger Rejection

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

  Patient problems: Capsular Contracture

  MAUDE report 24308979 ↗
• InjuryDec 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AND EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED AND WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23745803 ↗
• InjuryDec 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORTED CAPSULAR CONTRACTURE BAKER GRADE III AND EXCHANGE OF TEXTURED DEVICES DUE TO PATIENT'S CONCERN". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE REMAINS IMPLANTED AND WILL BE RETURNED.

  Patient problems: Capsular Contracture

  MAUDE report 23723986 ↗
• InjurySep 26, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  HEALTHCARE PROFESSIONAL REPORT A RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND AN IMPLANT REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. LATER HEALTHCARE PROFESSIONAL REPORTED "BIOCELL". DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Capsular Contracture

  MAUDE report 23158353 ↗
• InjuryJan 9, 2020Fluid/Blood Leak; Patient-Device Incompatibility; Fluid/Blood Leak; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 9569551 ↗
• InjuryMay 17, 2019Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT-SIDE "POSSIBLE DEFLATION." DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 8621519 ↗
• InjuryApr 4, 2018Fluid/Blood Leak; Patient-Device Incompatibility; Fluid/Blood Leak; Patient-Device Incompatibility

  HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture; Failure of Implant

  MAUDE report 7397203 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990074. One submission often covers many models, so check the product and lot details in each record.

• Z-0699-2020 · Nov 6, 2019 · Terminated
  Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 108886280
• Z-0336-06 · Dec 14, 2005 · Terminated
  McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
• Z-0337-06 · Dec 14, 2005 · Terminated
  McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
• Z-0851-05 · May 5, 2005 · Terminated
  Style 363 Saline-Filled BIOCELL textured Breast Implants