MENTOR CPX 4 Breast Tissue ExpanderRecalls & reported problems across all models
Mentor Texas L.P. · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 96
- Deaths reported
- 0
- Injuries reported
- 88
- Recalls
- 0
We found 15 models of MENTOR CPX 4 Breast Tissue Expander by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 96 adverse event reports in the FDA's MAUDE database, received between Mar 7, 2018 and Mar 5, 2026 — classified as 88 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (78 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MENTOR CPX 4 Breast Tissue Expander problems
Device problems
- Material Rupture78
- Adverse Event Without Identified Device or Use Problem12
- Off-Label Use3
- Inflation Problem2
- Migration2
- Appropriate Device Problem Term/Code Not Available1
- Component Missing1
- Deflation Problem1
Patient problems
- No Code Available48
- Deformity/ Disfigurement31
- No Clinical Signs, Symptoms or Conditions7
- Seroma5
- Unspecified Infection4
- No Consequences Or Impact To Patient3
- Post Operative Wound Infection2
- Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)1
MENTOR CPX 4 Breast Tissue Expander models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR CPX 4 Breast Tissue Expander 3548213EXPANDER, SKIN, INFLATABLE22 reports
- MENTOR CPX 4 Breast Tissue Expander 3548214EXPANDER, SKIN, INFLATABLE20 reports
- MENTOR CPX 4 Breast Tissue Expander 3548215EXPANDER, SKIN, INFLATABLE12 reports
- MENTOR CPX 4 Breast Tissue Expander 3548212EXPANDER, SKIN, INFLATABLE9 reports
- MENTOR CPX 4 Breast Tissue Expander 3548314EXPANDER, SKIN, INFLATABLE6 reports
- MENTOR CPX 4 Breast Tissue Expander 3548315EXPANDER, SKIN, INFLATABLE6 reports
- MENTOR CPX 4 Breast Tissue Expander 3548114EXPANDER, SKIN, INFLATABLE4 reports
- MENTOR CPX 4 Breast Tissue Expander 3548211EXPANDER, SKIN, INFLATABLE4 reports
- MENTOR CPX 4 Breast Tissue Expander 3548216EXPANDER, SKIN, INFLATABLE4 reports
- MENTOR CPX 4 Breast Tissue Expander 3548316EXPANDER, SKIN, INFLATABLE3 reports
- MENTOR CPX 4 Breast Tissue Expander 3548313EXPANDER, SKIN, INFLATABLE2 reports
- MENTOR CPX 4 Breast Tissue Expander 3548112EXPANDER, SKIN, INFLATABLE1 report
- MENTOR CPX 4 Breast Tissue Expander 3548115EXPANDER, SKIN, INFLATABLE1 report
- MENTOR CPX 4 Breast Tissue Expander 3548311EXPANDER, SKIN, INFLATABLE1 report
- MENTOR CPX 4 Breast Tissue Expander 3548312EXPANDER, SKIN, INFLATABLE1 report
Recent MENTOR CPX 4 Breast Tissue Expander adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH A 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST INFECTION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.
Patient problems: Post Operative Wound Infection
MAUDE report 24523877 ↗MalfunctionDec 4, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ONE 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WAS RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB ON OCTOBER 27, 2025, 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 23718931 ↗InjuryJul 30, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 22669047 ↗InjuryApr 30, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT WHO HAD A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER PLACED EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19215803 ↗InjuryMar 18, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 18925387 ↗InjuryMar 13, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18894860 ↗InjuryMar 11, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 56-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER AND EXPERIENCED EXPANDER DEFLATION ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE EXPANDER WAS EXPLANTED ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18875919 ↗InjuryMar 8, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER, 550CC SALINE BREAST IMPLANT EXPERIENCED LEFT-SIDED DEFLATION POSTOPERATIVE. . AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 18870686 ↗InjuryFeb 27, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER ON AN UNSPECIFIED BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18792976 ↗InjuryFeb 23, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER ON THE RIGHT BREAST AND SUFFERED DEFLATION, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICE WAS ANOTHER 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER (CATALOG: 3548213).
Patient problems: Deformity/ Disfigurement
MAUDE report 18772935 ↗MalfunctionJan 9, 2024Component Missing; Component Missing
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX 4 BREAST, 650CC TISSUE EXPANDER EXPERIENCED UNKNOWN SIDED MISSING COMPONENT POST PROCEDURE. THE DOCTOR NOTICED THE EXPANDER MISSING A GREEN NEEDLE. NO PATIENT CONSEQUENCES OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18480701 ↗InjuryDec 27, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER, 550CC TISSUE EXPANDER SALINE IMPLANT, EXPERIENCED UNKNOWN- SIDED DEFLATION POST PROCEDURE. IMAGING CONFIRMED THE ISSUE. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 18400920 ↗InjuryOct 31, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 450CC DEVICE THAT DEFLATED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNKNOWN DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 18044360 ↗InjuryOct 25, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 450CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNKNOWN DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 18007013 ↗InjuryAug 24, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST TISSUE EXPANDER BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH AN UNDISCLOSED LEFT-SIDED TISSUE EXPANDER ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 17611782 ↗
Other Mentor Texas L.P. products
- MENTOR MemoryGel Breast Implants368 models · 56,155 reports
- MENTOR MemoryGel Breast Implant211 models · 49,379 reports
- MENTOR Smooth Round Moderate Profile20 models · 14,918 reports · 1 recall
- MENTOR Smooth Round Moderate Plus Profile22 models · 6,091 reports · 1 recall
- MENTOR MemoryGel Xtra Breast Implant88 models · 5,679 reports
- MENTOR Smooth Round High Profile17 models · 4,098 reports · 1 recall
- MENTOR SILTEX Round Moderate Profile13 models · 2,160 reports
- MENTOR MemoryShape Breast Implant65 models · 1,595 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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