MENTOR CPX4 PLUS, Smooth, Medium Height SCPX135MHRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10081317028380), received between Nov 17, 2021 and Aug 18, 2026 — classified as 18 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (16 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50304531 ↗
• MalfunctionApr 15, 2026Material Deformation

  IT WAS REPORTED THAT SURGEON REMOVED A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER FROM ITS PACKAGING AND WHEN THE DEVICE WAS FILLED WITH AIR, THE SURGEON NOTICED A CLEAR SHAPE ON THE LOWER POLE. THE SURGEON WAS NOT COMFORTABLE USING THE EXPANDER AND USED A DIFFERENT EXPANDER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889256 ↗
• MalfunctionDec 18, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A HAIR WAS OBSERVED IN THE PACKAGING OF A 550CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER PRE-OPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842894 ↗
• InjuryJun 23, 2025Material Rupture; Use of Device Problem; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT WITH A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL. THE DEVICE WAS IMPLANTED LONGER THAN SIX MONTHS, WHICH IS AN OFF-LABEL USE OF THE DEVICE PER THE IFU.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22307950 ↗
• InjuryMay 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 550CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST TISSUE EXPANDER. AS A RESULT, THE PATIENT UNDERWENT TISSUE EXPANDER REMOVAL ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22088690 ↗
• InjuryMar 5, 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 RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, REPLACEMENT WITH MENTOR GEL WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21526059 ↗
• InjuryFeb 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDERS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND BILATERAL DEFLATION 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. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21326588 ↗
• InjuryFeb 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDERS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND BILATERAL DEFLATION 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. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Capsular Contracture

  MAUDE report 21326585 ↗
• InjuryDec 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT 550CC TISSUE EXPANDERS THAT BOTH DEFLATED POST IMPLANTATION. BILATERAL DEFLATION WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT 550CC TISSUE EXPANDERS ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST TISSUE EXPANDER.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20920759 ↗
• InjuryDec 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT 550CC TISSUE EXPANDERS THAT BOTH DEFLATED POST IMPLANTATION. BILATERAL DEFLATION WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT 550CC TISSUE EXPANDERS ON (B)(6) 2024. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST TISSUE EXPANDER.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20916119 ↗
• InjuryNov 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT, 550CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION POSTOPERATIVE. THE PATIENT SYMPTOMS DIAGNOSED THE ISSUE. AS THE RESULT, PATIENT UNDERWENT REPLACEMENT WITH UNSPECIFIED IMPLANT ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20698449 ↗
• InjuryNov 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT 550CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST TISSUE EXPANDER WAS DIAGNOSED VIA A HEALTHCARE PROFESSIONAL¿S EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20695698 ↗
• InjurySep 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION WITH A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT, 550CC SALINE PROSTHESIS EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVE. LEAK WAS FOUND AT 3'OCLOCK POSITION WHERE THE PORT MEETS AT THE SEEM OF THE EXPANDER. THE ISSUE WAS DISCOVERED DURING THE SURGERY. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS WITH CAT: SHPX-650 ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20137288 ↗
• 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 AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT 550CC TISSUE EXPANDER AND PRESENTED WITH NECROSIS OF THE MASTECTOMY INCISION ON THE RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT A SURGICAL INTERVENTION ON AN UNKNOWN DATE. THE PATIENT LATER UNDERWENT EXPLANTATION OF THE RIGHT TISSUE EXPANDER IN (B)(6) 2023. THE FLUID WAS SENT TO PATHOLOGY AND IT WAS FOUND TO HAVE PSEUDOMONAS AERUGINOSA.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20091654 ↗
• InjuryAug 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 550CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT FAT GRAFTING AND REPLACEMENT WITH MENTOR GEL IMPLANTS ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20088297 ↗
• InjuryJun 17, 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 19548065 ↗
• InjuryFeb 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 550CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDERS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT DEFLATIONS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18717407 ↗
• InjuryFeb 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 550CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDERS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT DEFLATIONS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18717404 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT 550CC TISSUE EXPANDERS DEVELOPED PAIN IN BOTH OF HER BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT SUFFERED FROM ¿OTHER SYMPTOMS¿ THAT WERE NOT SPECIFIED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE 2ND OF THE PATIENT¿S TWO TISSUE EXPANDERS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 18495513 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT 550CC TISSUE EXPANDERS DEVELOPED PAIN IN BOTH OF HER BREASTS POST IMPLANTATION. ADDITIONALLY, THE PATIENT SUFFERED FROM ¿OTHER SYMPTOMS¿ THAT WERE NOT SPECIFIED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE 1ST OF THE PATIENT¿S TWO TISSUE EXPANDERS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 18495505 ↗
• MalfunctionMay 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 550CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER WAS PLACED INTO THE PATIENT AND INFLATED DURING A BREAST SURGERY. SUBSEQUENTLY, IT WAS OBSERVED THAT THE EXPANDER VISIBLY DEFLATED. UPON INSPECTION, THERE WAS A HOLE ON THE EXPANDER PATCH. NO FURTHER INFORMATION WAS PROVIDED. THERE WERE NO REPORTED ADVERSE EVENTS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032096 ↗
• InjuryNov 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WITH A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT 550CC TISSUE EXPANDER 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 MENTOR TISSUE EXPANDER (SERIAL NUMBER (B)(4)) ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12832403 ↗