MENTOR CPX4 PLUS, Smooth, Medium Height SCPX117MHRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10081317028366), received between Mar 8, 2022 and Jul 18, 2025 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 74-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 350CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22546460 ↗
• InjuryJun 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER EXPERIENCED SPONTANEOUS RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22122540 ↗
• MalfunctionMar 6, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A 350CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER BEING USED IN A BREAST SURGERY WAS FOUND TO HAVE A HAIR WHEN OPENING THE PACKAGE. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT; HOWEVER, A PROCEDURAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21538413 ↗
• InjuryNov 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDERS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR GEL BREAST IMPLANTS ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20725362 ↗
• InjuryAug 25, 2023Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT A 66-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT WAS SEEN FOR A REVISION SURGERY. DURING THE REVISION SURGERY, IT WAS DISCOVERED THAT THE PATIENT EXPERIENCED A DEFLATION OF HER LEFT PROSTHESIS. THE SURGEON ALSO REPORTED THAT THE DOME OF THE DEVICE HAD SEPARATED FROM THE SHELL, CAUSING LEAKING. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 545CC MENTOR MEMORYGEL BOOST BREAST IMPLANT ON (B)(6), 2023. THERE WERE NO PROCEDURAL DELAYS OR ADDITIONAL PATIENT CONSEQUENCES REPORTED DUE TO THE DEFLATION THAT WAS DISCOVERED DURING THE REVISION SURGERY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17623780 ↗
• InjuryAug 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 66-YEAR-OLD ASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT EXPERIENCED A DEFLATION OF HER LEFT PROSTHESIS, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17454862 ↗
• MalfunctionJul 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 350CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT BEING USED FOR BREAST SURGERY PROCEDURE WAS FOUND RUPTURED INTRAOPERATIVELY. IT WAS REPORTED THAT THE PRODUCT WAS OPENED WHILE THE PATIENT WAS ON THE TABLE AND WHILE INSPECTING THE CPX4 EXPANDER, THE SURGEON NOTICED WHAT LOOKED LIKE A HOLE IN THE EXPANDER. SHE WASN¿T COMFORTABLE USING IT, SO THEY GRABBED ANOTHER EXPANDER FROM THEIR CONSIGNMENT AND USED THAT ONE ON THE PATIENT. THE SURGEON SAID IT WAS A VERY MINOR DELAY AND NO EXTRA RISK TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17289161 ↗
• InjuryApr 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION WITH A 350CC MENTOR CPX4 PLUS SMOOTH MEDIUM HEIGHT TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, REPLACEMENT WITH A NEW MENTOR TISSUE EXPANDER WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16796752 ↗
• InjuryDec 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 55-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 350CC MENTOR CPX4 PLUS SMOOTH MEDIUM HEIGHT TISSUE EXPANDER EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, REPLACEMENT WITH 450CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE PROSTHESES WAS PERFORMED ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16010655 ↗
• InjuryNov 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 48-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 350CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15716735 ↗
• MalfunctionOct 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER BEING USED IN AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WAS FOUND TO BE DEFLATED DURING THE OPERATION. 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 15533682 ↗
• InjuryMar 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH AN UNKNOWN TISSUE EXPANDER BREAST IMPLANT EXPERIENCED UNKNOWN-SIDED DEFLATION POST PROCEDURE. THE ISSUE WAS CONFIRMED BY THE HEALTH CARE PROFESSIONAL. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6), 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13695533 ↗