NATRELLE Saline-Filled Breast Implants 168-650Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888628000919), received between Jan 25, 2018 and Jun 13, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROVIDER REPORTED A RIGHT SIDE DEFLATION. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17121432 ↗
• InjuryJul 12, 2022Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection

  PATIENT REPORTED RIGHT SIDE EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "CAPSULAR CONTRACTURE, BAKER GRADE IV" AND "DEFLATION." DEVICE WAS EXPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14990624 ↗
• InjuryJun 30, 2022Fluid/Blood Leak; Device Appears to Trigger Rejection; Fluid/Blood Leak; Device Appears to Trigger Rejection

  PATIENT REPORTED LEFT SIDE DEFLATION AND EXCHANGE FROM TEXTURED TO SMOOTH IMPLANTS DUE TO THE PATIENTS CONCERNS WITH THE PRODUCT. ADDITIONALLY, HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE "CAPSULAR CONTRACTURE BAKER GRADE IV." DEVICE REMAINS IMPLANTED.

  Patient problems: Capsular Contracture

  MAUDE report 14881451 ↗
• InjuryJun 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROVIDER OFFICE CALLED TO REPORT A RIGHT -SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 14581287 ↗
• InjuryJan 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROVIDER REPORTED BILATERAL DEFLATION. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9547845 ↗
• InjuryJan 25, 2018Fluid/Blood Leak; Fluid/Blood Leak

  HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 7219228 ↗

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-0337-06 · Dec 14, 2005 · Terminated
  McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
• Z-0336-06 · Dec 14, 2005 · Terminated
  McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
• Z-0851-05 · May 5, 2005 · Terminated
  Style 363 Saline-Filled BIOCELL textured Breast Implants