Mentor CPX4 with suture tabs, med height, smooth 3509213Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00081317026662), received between Jul 10, 2019 and Oct 20, 2022 — 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.

• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 61-YEAR-OLD BLACK FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT REPORTED SHE HAD THREE LYMPH NODES REMOVED AND HAD CAPSULAR CONTRACTURE; HOWEVER, NO BAKER GRADES WERE PROVIDED AS SHE HASN¿T CONSULTED WITH A MEDICAL PROFESSIONAL. ADDITIONALLY, SHE HAD AN INFECTION ASSOCIATED WITH HER LEFT BREAST AS A LIME GREEN SUBSTANCE WAS PRESENT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-12671 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture; Post Operative Wound Infection; Swollen Lymph Nodes/Glands

  MAUDE report 15642366 ↗
• InjuryJul 10, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH CPX4 WITH SUTURE TABS MEDIUM HEIGHT SMOOTH EXPANDER AND EXPERIENCED A DEFLATION AND A BROKEN SUTURE TAB ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8776160 ↗