MENTOR CPX 2 Breast Tissue ExpanderRecalls & reported problems across all models
Mentor Texas L.P. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 0
We found 11 models of MENTOR CPX 2 Breast Tissue Expander by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Mar 30, 2018 and Feb 23, 2026 — classified as 18 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (15 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 2 Breast Tissue Expander problems
Device problems
- Material Rupture15
- Adverse Event Without Identified Device or Use Problem5
- No Apparent Adverse Event2
- Use of Device Problem2
- Off-Label Use1
Patient problems
- No Code Available13
- Deformity/ Disfigurement4
- Breast Mass2
- No Patient Involvement2
- Seroma2
- Unspecified Infection2
- Autoimmune Reaction1
- Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)1
MENTOR CPX 2 Breast Tissue Expander models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR CPX 2 Breast Tissue Expander 3546215EXPANDER, SKIN, INFLATABLE4 reports
- MENTOR CPX 2 Breast Tissue Expander 3546112EXPANDER, SKIN, INFLATABLE3 reports
- MENTOR CPX 2 Breast Tissue Expander 3546111EXPANDER, SKIN, INFLATABLE2 reports
- MENTOR CPX 2 Breast Tissue Expander 3546113EXPANDER, SKIN, INFLATABLE2 reports
- MENTOR CPX 2 Breast Tissue Expander 3546212EXPANDER, SKIN, INFLATABLE2 reports
- MENTOR CPX 2 Breast Tissue Expander 3546213EXPANDER, SKIN, INFLATABLE2 reports
- MENTOR CPX 2 Breast Tissue Expander 3546214EXPANDER, SKIN, INFLATABLE1 report
- MENTOR CPX 2 Breast Tissue Expander 3546216EXPANDER, SKIN, INFLATABLE1 report
- MENTOR CPX 2 Breast Tissue Expander 3546311EXPANDER, SKIN, INFLATABLE1 report
- MENTOR CPX 2 Breast Tissue Expander 3546312EXPANDER, SKIN, INFLATABLE1 report
- MENTOR CPX 2 Breast Tissue Expander 3546313EXPANDER, SKIN, INFLATABLE1 report
Recent MENTOR CPX 2 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.
InjuryFeb 23, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION WITH A 250CC MENTOR CPX 2 BREAST TISSUE EXPANDER ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT VOLUME LOSS AND FLATTENING, POSSIBLE LEAK. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 24423209 ↗InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 350CC MENTOR CPX 2 BREAST TISSUE EXPANDER PROSTHESIS. POST-OPERATIVELY, THE PATIENT REPORTED HAVING HAD A POSITRON EMISSION TOMOGRAPHY (PET) SCAN PERFORMED WHICH INDICATED A PROMINENT LEFT BREAST LYMPH NODE. A BIOPSY AND EXCISION OF THE NODE WAS PERFORMED. AFTERWARDS, SHE BEGAN TO EXPERIENCE LEFT BREAST SWELLING AND PAIN. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL LEFT BREAST IMPLANT REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2024. DURING THE SURGERY, APPROXIMATELY 400CC OF FLUID WAS DRAINED FROM THE LEFT BREAST. SHE STATES A POTENTIAL DIAGNOSIS OF LEFT-SIDED BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL) PER THE HEALTH PROFESSIONALS SUSPICIONS. PATHOLOGY RESULTS HAVE NOT BEEN PROVIDED AS OF YET. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.
Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Lymphoma; Seroma; Swollen Lymph Nodes/Glands
MAUDE report 20753443 ↗InjuryFeb 7, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A 650CC MENTOR CPX 2 BREAST TISSUE EXPANDER EXPERIENCED LEFT SIDED RUPTURE ACCOMPANIED BY DISFIGUREMENT POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 18664599 ↗InjurySep 11, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR MEMORYGEL BREAST IMPLANT 650CC GEL BREAST PROSTHESIS (LEFT DEVICE) AND A MENTOR CPX 2 BREAST TISSUE EXPANDER 450CC DEVICE (RIGHT DEVICE) THAT BOTH RUPTURED POST IMPLANTATION. BILATERAL RUPTURE WAS DIAGNOSED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 800CC GEL BREAST PROSTHESES ON (B)(6)2023. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 17721945 ↗InjuryJun 16, 2022Material Rupture; Use of Device Problem; Material Rupture; Use of Device Problem
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 650CC MENTOR CPX 2 BREAST TISSUE EXPANDER ON BOTH SIDES AND EXPERIENCED BILATERAL DEFLATION, AND BILATERAL BREAST MASS POSTOPERATIVELY. THE PATIENT ALSO WANTED VERIFICATION ON THE UPCOMING KNEE SURGERY, AND TO FIND OUT IF EXPANDERS ARE MRI COMPATIBLE. THE PATIENT HAS CONSULTED WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.
Patient problems: Breast Mass
MAUDE report 14719432 ↗InjuryJun 16, 2022Material Rupture; Use of Device Problem; Material Rupture; Use of Device Problem
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 650CC MENTOR CPX 2 BREAST TISSUE EXPANDER ON BOTH SIDES AND EXPERIENCED BILATERAL DEFLATION, AND BILATERAL BREAST MASS POSTOPERATIVELY. THE PATIENT ALSO WANTED VERIFICATION ON THE UPCOMING KNEE SURGERY, AND TO FIND OUT IF EXPANDERS ARE MRI COMPATIBLE. THE PATIENT HAS CONSULTED WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.
Patient problems: Breast Mass
MAUDE report 14719272 ↗InjuryJun 4, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture
IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 350CC MENTOR CPX 2 BREAST TISSUE EXPANDER THAT DEFLATED POSTOPERATIVELY. AS A RESULT, THE PATIENT HAD THE DEVICE EXPLANTED ON (B)(6) 2021. THE PATIENT HAS SINCE RECOVERED FULLY. THE DEVICE WAS IMPLANTED ON (B)(6) 2016. THESE DEVICES ARE INDICATED FOR USE FOR A PERIOD OF SIX MONTHS, AND AS SUCH, THIS DEVICE WAS USED OFF-LABEL.
Patient problems: Deformity/ Disfigurement
MAUDE report 11939939 ↗InjuryMar 12, 2020Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 250CC MENTOR CPX 2 BREAST TISSUE EXPANDER, SUFFERED DEFLATION ON AN UNSPECIFIED SIDE, POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: No Code Available
MAUDE report 9827602 ↗InjuryAug 30, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 350CC MENTOR CPX 2 BREAST TISSUE EXPANDER AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT ON (B)(6) 2019.
Patient problems: No Code Available
MAUDE report 8951916 ↗InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6)-YEAR OLD FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX 2 BREAST TISSUE EXPANDER ON THE RIGHT SIDE, SUFFERED LARGE AMOUNT OF SEROMA POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A MENTOR GEL IMPLANT ON (B)(6) 2017. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR ASR/PSR REFERENCE NUMBER (B)(4).
Patient problems: No Code Available; Seroma
MAUDE report 8941359 ↗InjuryAug 20, 2019Material Rupture; Material Rupture
THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR ASR/PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A PATIENT WITH UNKNOWN AGE, RACE, AND SEX UNDERWENT UNSPECIFIED BREAST AUGMENTATION WITH A 550CC MENTOR CPX 2 BREAST TISSUE EXPANDER AND WAS PRESENTED WITH UNKNOWN SIDE DEFLATION. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2017.
Patient problems: No Code Available
MAUDE report 8912289 ↗MalfunctionJul 16, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH MENTOR CPX 2 BREAST TISSUE EXPANDERS 350CC AND EXPERIENCED SICKNESS, LOSS OF MOVEMENT ON THE RIGHT SIDE, NECK PAIN, BACK PAIN, AND DEFLATION ON THE RIGHT SIDE. THE DEFLATION WAS DISCOVERED DURING EXPLANTATION ON (B)(6) 2019. IT IS UNKNOWN WHICH SIDE EACH DEVICE CORRESPONDS TO. THIS REPORT HAS BEEN DEFAULTED TO THE LEFT SIDE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING DEVICE INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED.
Patient problems: No Code Available; No Patient Involvement
MAUDE report 8795168 ↗MalfunctionJul 16, 2019Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH MENTOR CPX 2 BREAST TISSUE EXPANDERS 350CC AND EXPERIENCED SICKNESS, LOSS OF MOVEMENT ON THE RIGHT SIDE, NECK PAIN, BACK PAIN, AND DEFLATION ON THE RIGHT SIDE. THE DEFLATION WAS DISCOVERED DURING EXPLANTATION ON (B)(6) 2019. IT IS UNKNOWN WHICH SIDE EACH DEVICE CORRESPONDS TO. THIS REPORT HAS BEEN DEFAULTED TO THE RIGHT SIDE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING DEVICE INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED.
Patient problems: No Code Available; No Patient Involvement
MAUDE report 8795158 ↗InjuryMay 15, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR CPX 2 BREAST TISSUE EXPANDER 450CC DEVICE THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE LEFT SIDE TISSUE EXPANDER WAS DETECTED BY BOTH ULTRASOUND AND MRI. IN ADDITION, A SILICONE INFILTRATION IN THE AXILLARY LYMPH NODE WAS CONFIRMED BY A CORE BIOPSY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019.
Patient problems: Granuloma; No Code Available
MAUDE report 8612966 ↗InjuryDec 26, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION WITH A 350 CC MENTOR CPX 2 BREAST TISSUE EXPANDER. THE EXPANDER WAS IMPLANTED AFTER THE PATIENT WENT THROUGH A BREAST CANCER SURGERY IN 2012 AND IT WAS REPORTED TO HAVE BEEN DEFECTIVE FROM THE BEGINNING AND ALSO HAD LEAKAGE. IT WAS ALSO REPORTED THAT THE PATIENT ASSUMED IT WAS PERFORATED DURING SURGERY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: No Code Available
MAUDE report 8196710 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page