MENTOR CPX4 PLUS, Smooth, Medium Height SCPX156MHRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10081317028403), received between Mar 16, 2021 and Jun 2, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Use of Device Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 800CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER AND HAD AN IMPLANT INSERTED AFTER THE EXPIRATION DATE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Insufficient Information

  MAUDE report 25367908 ↗
• InjuryMar 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 800CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDERS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT DEFLATIONS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6). 2025. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21540632 ↗
• InjuryMar 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 800CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDERS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT DEFLATIONS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2025. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21540630 ↗
• InjuryOct 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN 800CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20385794 ↗
• MalfunctionDec 5, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ONE MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT WAS RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB ON NOVEMBER 7, 2023 WITH NO ACCOMPANYING INFORMATION. THE DEVICE COULD NOT BE ASSOCIATED WITH AN EXISTING COMPLAINT. IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHY THIS DEVICE WAS RETURNED TO MENTOR. HOWEVER, THE RETURN OF A PROSTHESIS IS CHARACTERISTIC OF A REMOVAL AND REPLACEMENT SURGERY. AS A RESULT, THIS WILL BE CONSERVATIVELY REPORTED TO FDA.

  Patient problems: Insufficient Information

  MAUDE report 18268057 ↗
• InjurySep 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER AND EXPERIENCED DEFLATION (SIDE UNKNOWN) POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17690685 ↗
• InjuryMay 11, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH A 800CC CPX4 PLUS SMOOTH MEDIUM HEIGHT TISSUE EXPANDER EXPERIENCED RIGHT SIDED DEFECTIVE DEVICE POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14354477 ↗
• MalfunctionApr 29, 2022Filling Problem; Filling Problem

  IT WAS REPORTED THAT A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER WAS USED IN A BREAST RECONSTRUCTION PRIMARY SURGERY. WHEN TRYING TO REMOVE AIR FROM THE TISSUE EXPANDER, THE BUTTERFLY NEEDLE BROKE IN THE INJECTION PORT. THE SURGEON DID NOT WANT TO IMPLANT FOR FEAR OF PIECES OF NEEDLE REMAINING. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250491 ↗
• InjuryMar 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 800CC CPX4 PLUS SMOOTH MEDIUM HEIGH TISSUE EXPANDER AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION. THE PATIENT HAD A CONSULTATION WITH A HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11499011 ↗