MENTOR CPX4 PLUS, Smooth, Tall Height SCPX123THRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10081317028434), received between Jun 14, 2022 and Sep 11, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT 450CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. THE PATIENT FIRST NOTICED VOLUME LOSS IN HER LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. DURING EXPLANT SURGERY, THE SURGEON CONFIRMED DEFLATION OF THE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23031214 ↗
• MalfunctionDec 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT, 450 CC SALINE TISSUE EXPANDER PROSTHESIS EXPERIENCED UNKNOWN SIDED DEFLATION INTRAOPERATIVE. NO PATIENT CONSEQUENCES REPORTED, OR NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20826340 ↗
• MalfunctionNov 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT 450CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION INTRAOPERATIVE. THE DEFECTIVE IMPLANT NOT IN CONTACT WITH PATIENT, AND NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20666328 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT TISSUE EXPANDERS 450CC AND EXPERIENCED BILATERAL BREAST INFECTIONS POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20147692 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA MEDSUN # (B)(4) THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT TISSUE EXPANDERS 450CC AND EXPERIENCED INFECTION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20089236 ↗
• MalfunctionSep 2, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING A PRIMARY BREAST RECONSTRUCTION PROCEDURE, A SURGEON WAS ATTEMPTING TO INFLATE A CPX4 PLUS SMOOTH TALL HEIGHT 450CC DEVICE ON THE RIGHT SIDE BUT COULD NOT INFLATE IT. THE DEVICE DID NOT TOUCH THE PATIENT AND WAS NOT IMPLANTED IN THE PATIENT. PROCEDURE CONTINUED USING CATALOG NUMBER SCPX123TH; SERIAL NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15348390 ↗
• InjuryJun 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION SURGERY WITH A 450CC CPX4 PLUS SMOOTH TALL HEIGHT EXPERIENCED RIGHT SIDED BREAST PAIN AND DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A LIKE DEVICE ON (B)(6) 2022.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 14691149 ↗