Mentor CPX4 with suture tabs, med height, smooth 3509214Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00081317026679), received between Aug 27, 2019 and Nov 4, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2022Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH TISSUE EXPANDERS AND EXPERIENCED BILATERAL DEVICE MIGRATION POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15725001 ↗
• InjuryNov 4, 2022Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH TISSUE EXPANDERS AND EXPERIENCED BILATERAL DEVICE MIGRATION POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15724909 ↗
• InjuryAug 27, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH A 550CC MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH BREAST TISSUE EXPANDER AND EXPERIENCED POSTOPERATIVE LEFT-SIDED DEFLATION. THE DIAGNOSIS WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 550CC MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH ( CATALOG #:3509214, SERIAL #:(B)(4)) ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8936982 ↗