MENTOR CPX4 PLUS, Smooth, Medium Height SCPX146MHRecalls & reported problems
Mentor Texas L.P. · Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 650CC · Class U · Implant
All models of MENTOR CPX4 PLUS, Smooth, Medium Height (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10081317028397), received between Aug 10, 2022 and Feb 24, 2026 — classified as 16 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (17 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 16, 2026.
Reports received per month
Recalls naming this device
- 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
Device problems
- Material Rupture17
- Material Deformation1
Patient problems
- Deformity/ Disfigurement16
- No Clinical Signs, Symptoms or Conditions2
- Post Operative Wound Infection1
- Seroma1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2026Material Rupture
IT WAS REPORTED THAT A 49-YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A 650CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED DURING SURGERY. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2026 AND REPLACED WITH A 590CC MENTOR MEMORYGEL BOOST BREAST IMPLANT.
Patient problems: Deformity/ Disfigurement
MAUDE report 24431758 ↗InjuryFeb 19, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH LEFT BREAST IMPLANT RUPTURE. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 24385256 ↗InjuryOct 31, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 650CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER.
Patient problems: Deformity/ Disfigurement
MAUDE report 23442393 ↗InjuryJan 22, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 58-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT 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) 2024, AND REPLACED WITH A 650CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUES EXPANDER (CATALOG NUMBER SCPX146MH) WITH SERIAL NUMBER (B)(6).
Patient problems: Deformity/ Disfigurement
MAUDE report 21210584 ↗InjuryNov 12, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED A LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT WAS A MENTOR GEL IMPLANT.
Patient problems: Deformity/ Disfigurement
MAUDE report 20666908 ↗InjuryOct 17, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY 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 REMOVAL ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 20474391 ↗InjuryJun 20, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 650CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER EXPERIENCED A DEFLATION, WOUND INFECTION, AND A SEROMA ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement; Post Operative Wound Infection; Seroma
MAUDE report 19577176 ↗InjuryJun 5, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED LEFT BREAST IMPLANT DEFLATION. THERE WAS A TEAR AMONGST THE SEEM. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19472469 ↗InjuryJun 5, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 650CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 19472277 ↗InjuryJun 3, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT, 650CC SALINE TISSUE EXPANDER EXPERIENCED RIGHT-SIDED DEFLATION POST-OPERATION. AS A RESULT, PATIENT UNDERWENT UNILATERAL REPLACEMENT WITH RIGHT/ PRODUCT CODE SCPX146MH; LOT/SERIAL NUMBER (B)(6) ON (B)(6) 2024. TWO EXPANDERS WAS USED AND THEY BOTH HAD TEAR AT THE SEEM. THE LEFT SIDE WILL BE REPORTED IN (B)(4).
Patient problems: Deformity/ Disfigurement
MAUDE report 19454589 ↗InjuryMar 21, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 650CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT AND EXPERIENCED EXPANDER DEFLATION ON HER RIGHT SIDE. AS A RESULT, THE EXPANDER WAS EXPLANTED ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18949050 ↗InjuryMar 11, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 56-YEAR-OLD FEMALE PATIENT UNDERWENT BREAST SURGERY WITH A 650CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT AND EXPERIENCED EXPANDER DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE EXPANDER WAS EXPLANTED ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18875418 ↗InjuryFeb 15, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 650CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER ON THE RIGHT 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 18717258 ↗InjurySep 8, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 56-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 650CC 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) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 17712484 ↗MalfunctionAug 2, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER BEING USED IN A 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 17443414 ↗InjuryJun 21, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A 53-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 650CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT EXPERIENCED A DEFLATION OF HER RIGHT PROSTHESIS, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 560CC MENTOR MEMORYGEL XTRA BREAST IMPLANT ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 17174137 ↗InjuryNov 8, 2022Material Rupture; Material Rupture
IT WAS REPORTED THAT A 58-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR CPX4 PLUS SMOOTH MEDIUM HEIGHT 650CC TISSUE EXPANDER EXPERIENCED SPONTANEOUS LEFT SIDED DEFLATION POST PROCEDURE. TINY HOLES IN THE EXPANDER AND LOSS OF VOLUME WERE NOTED. REPLACEMENT WITH A NEW MENTOR CPX4 PLUS SMOOTH MEDIUM HEIGHT 650CC TISSUE EXPANDER WAS PERFORMED ON (B)(6) 2022.
Patient problems: Deformity/ Disfigurement
MAUDE report 15757295 ↗MalfunctionAug 10, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX4 PLUS SMOOTH MEDIUM HEIGHT 650CC, EXPANDER IMPLANT EXPERIENCED UNKNOWN-SIDED SHELL IRREGULARITIES INTRAOPERATIVELY. DOCTOR NOTICED THAT THE EXPANDER SEEMED TO HAVE A BUNCH OF MOBILE BUBBLES UNDER THE DACRON PATCH ON THE FRONT. THE BUBBLES SEEMED TO BE STUCK UNDER THE PATCH. THIS WAS NOTICED AFTER THE PATIENT WAS PREPPED AND THE SURGERY WAS UNDERWAY. SHE ELECTED TO OPEN A DIFFERENT IMPLANT. NO ADVERSE EVENT OR PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15204661 ↗
Other Expander, skin, inflatable devices
- B.BRAUN 7B3050B. Braun Medical Inc. · EXPANDER, SKIN, INFLATABLE1 recall40 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549314Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE1 recall22 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MX-13-TAllergan, Inc. · Expander, Skin, Inflatable1 recall16 reports
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC135UHMentor Texas L.P. · Expander, skin, inflatable1 recall14 reports
- MENTOR ARTOURA PLUS, Smooth, High Profile SDC150HMentor Texas L.P. · Expander, skin, inflatable1 recall14 reports
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC120UHMentor Texas L.P. · Expander, skin, inflatable1 recall14 reports
- MENTOR CPX4 PLUS, Smooth, Medium Height SCPX127MHMentor Texas L.P. · Expander, skin, inflatable1 recall13 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MV-14-TAllergan, Inc. · Expander, Skin, Inflatable1 recall13 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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