Mentor CPX4 with suture tabs, med height, smooth 3509215Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00081317026686), received between Feb 2, 2023 and Aug 30, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR 650CC MEDIUM HEIGHT SMOOTH CPX4 WITH SUTURE TABS EXPERIENCED LEFT SIDED ASYMMETRY AND SUBSEQUENT LEFT SIDED HEMATOMA POST PROCEDURE. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6), 2021. THIS EVENT IS ASSOCIATED WITH THE ATHENA CLINICAL TRIAL.

  Patient problems: Autoimmune Disorder; Deformity/ Disfigurement; Hematoma

  MAUDE report 17652001 ↗
• InjuryFeb 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 650CC MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH TISSUE EXPANDER, SUFFERED BREAST IMPLANT DEFLATION, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT EXPLANTATION SURGERY ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16287980 ↗