MENTOR CPX4 PLUS, Smooth, Medium Height SCPX107MHRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10081317028359), received between Jul 17, 2022 and Apr 13, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 18, 2026Class IIOpen, Classified

   Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

   Z-1683-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionApr 13, 2026Material Rupture

  IT WAS REPORTED THAT A HOLE WAS NOTICED ON 275CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT UPON OPENING THE PACKAGING. THERE WAS NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867702 ↗
• MalfunctionNov 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 275CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER BEING USED IN A BREAST SURGERY WAS FOUND TO BE DEFLATED PRIOR TO THE OPERATION. NO ADVERSE EVENT OR PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23662948 ↗
• InjuryJun 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH AN UNSPECIFIED MENTOR BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT EXPERIENCED A DEFLATION ON AN UNDISCLOSED SIDE, WHICH WAS CONFIRMED BY A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS 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.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19520867 ↗
• InjuryMar 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER 275CC 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 A NON-MENTOR DEVICE ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18922663 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 275CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL CAPSULAR CONTRACTURE OF UNDISCLOSED BAKER GRADE RATINGS DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH UNDISCLOSED NON-MENTOR BREAST IMPLANTS (B)(6) 2023. THE DATE OF EVENT WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. REFER TO MANUFACTURING REPORT NUMBER 1645337-2023-06583 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 17060904 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 275CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BILATERAL CAPSULAR CONTRACTURE OF UNDISCLOSED BAKER GRADE RATINGS DURING AN IN-OFFICE VISIT WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH UNDISCLOSED NON-MENTOR BREAST IMPLANTS (B)(6) 2023. THE DATE OF EVENT WAS PROVIDED TO MENTOR AS A BEST ESTIMATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY. REFER TO MANUFACTURING REPORT NUMBER (B)(6) 2023 FOR THE CONTRALATERAL EVENT.

  Patient problems: Capsular Contracture

  MAUDE report 17060232 ↗
• InjuryMar 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 275CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT ON AN UNSPECIFIED BREAST AND SUFFERED BREAST IMPLANT DEFLATION, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16482334 ↗
• InjuryMar 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDERS AND EXPERIENCED DEFLATION (SIDE UNKNOWN) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16471647 ↗
• InjuryJul 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 33-YEAR-OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 275CC CPX4 PLUS SMOOTH MEDIUM HEIGHT TISSUE EXPANDER EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A LIKE DEVICE ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15036669 ↗