MENTOR CPX4 PLUS, Smooth, Medium HeightRecalls & reported problems across all models
Mentor Texas L.P. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one MENTOR CPX4 PLUS, Smooth, Medium Height model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 83
- Deaths reported
- 0
- Injuries reported
- 63
- Recalls
- 1
We found 6 models of MENTOR CPX4 PLUS, Smooth, Medium Height by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 83 adverse event reports in the FDA's MAUDE database, received between Mar 16, 2021 and Aug 18, 2026 — classified as 63 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (65 reports).
1 FDA recall record name at least one of these models by its device 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. 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
MENTOR CPX4 PLUS, Smooth, Medium Height recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 18, 2026Open, 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 · names 3 of these models · Recall details · FDA record ↗
Most reported MENTOR CPX4 PLUS, Smooth, Medium Height problems
Device problems
- Material Rupture65
- Adverse Event Without Identified Device or Use Problem10
- Device Contamination with Chemical or Other Material3
- Material Deformation2
- Use of Device Problem2
- Appropriate Device Problem Term/Code Not Available1
- Defective Device1
- Filling Problem1
Patient problems
- Deformity/ Disfigurement52
- No Clinical Signs, Symptoms or Conditions18
- Seroma5
- Capsular Contracture4
- Post Operative Wound Infection4
- Breast Discomfort/Pain2
- Insufficient Information2
- Local Reaction1
MENTOR CPX4 PLUS, Smooth, Medium Height models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR CPX4 PLUS, Smooth, Medium Height SCPX146MHExpander, skin, inflatable1 recall18 reports
- MENTOR CPX4 PLUS, Smooth, Medium Height SCPX127MHExpander, skin, inflatable1 recall13 reports
- MENTOR CPX4 PLUS, Smooth, Medium Height SCPX107MHExpander, skin, inflatable1 recall9 reports
- MENTOR CPX4 PLUS, Smooth, Medium Height SCPX135MHExpander, skin, inflatable22 reports
- MENTOR CPX4 PLUS, Smooth, Medium Height SCPX117MHExpander, skin, inflatable12 reports
- MENTOR CPX4 PLUS, Smooth, Medium Height SCPX156MHExpander, skin, inflatable9 reports
Recent MENTOR CPX4 PLUS, Smooth, Medium Height adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJun 2, 2026Use of Device Problem
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 800CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER AND HAD AN IMPLANT INSERTED AFTER THE EXPIRATION DATE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Insufficient Information
MAUDE report 25367908 ↗MalfunctionMay 1, 2026Material Rupture
IT WAS REPORTED THAT A 450CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT BREAST IMPLANT EXPANDER HAD LEAKED. NO ADVERSE EVENTS, PATIENT HARMS, OR PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25058630 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗InjuryJul 18, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 74-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 350CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDER 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) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 22546460 ↗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 ↗InjuryJun 2, 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 SPONTANEOUS RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 22122540 ↗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 6, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 800CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDERS. POST-OPERATIVELY, THE PATIENT SUFFERED BILATERAL BREAST IMPLANT DEFLATIONS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL SURGERY ON (B)(6). 2025. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Deformity/ Disfigurement
MAUDE report 21540632 ↗
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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