MENTOR CPX4 PLUS, Smooth, Tall HeightRecalls & reported problems across all models
Mentor Texas L.P. · 5 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, Tall Height model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 1
We found 5 models of MENTOR CPX4 PLUS, Smooth, Tall Height by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Mar 11, 2022 and Dec 30, 2025 — classified as 17 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (19 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, Tall 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-1684-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported MENTOR CPX4 PLUS, Smooth, Tall Height problems
Device problems
- Material Rupture19
- Adverse Event Without Identified Device or Use Problem2
- Off-Label Use2
- Infusion or Flow Problem1
- Peeled/Delaminated1
Patient problems
- Deformity/ Disfigurement13
- No Clinical Signs, Symptoms or Conditions6
- Post Operative Wound Infection2
- Breast Discomfort/Pain1
MENTOR CPX4 PLUS, Smooth, Tall Height models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR CPX4 PLUS, Smooth, Tall Height SCPX140THExpander, skin, inflatable1 recall4 reports
- MENTOR CPX4 PLUS, Smooth, Tall Height SCPX113THExpander, skin, inflatable1 recall3 reports
- MENTOR CPX4 PLUS, Smooth, Tall Height SCPX123THExpander, skin, inflatable7 reports
- MENTOR CPX4 PLUS, Smooth, Tall Height SCPX132THExpander, skin, inflatable7 reports
- MENTOR CPX4 PLUS, Smooth, Tall Height SCPX146THExpander, skin, inflatable1 report
Recent MENTOR CPX4 PLUS, Smooth, Tall Height adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 30, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 16-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 350CC MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 350CC MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT TISSUE EXPANDER.
Patient problems: Deformity/ Disfigurement
MAUDE report 23927172 ↗InjuryNov 25, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT 550CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT TISSUE EXPANDER WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT 550CC TISSUE EXPANDER ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 23651088 ↗InjurySep 11, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT 450CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. THE PATIENT FIRST NOTICED VOLUME LOSS IN HER LEFT BREAST. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025. DURING EXPLANT SURGERY, THE SURGEON CONFIRMED DEFLATION OF THE DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 23031214 ↗InjuryAug 22, 2025Off-Label Use; Material Rupture; Off-Label Use; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 650CC MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT ON BOTH SIDES AND EXPERIENCED BILATERAL EXPANDER DEFLATION. AS A RESULT, THE EXPANDERS WERE EXPLANTED ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 22874423 ↗InjuryAug 22, 2025Off-Label Use; Material Rupture; Off-Label Use; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 650CC MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT ON BOTH SIDES AND EXPERIENCED BILATERAL EXPANDER DEFLATION. AS A RESULT, THE EXPANDERS WERE EXPLANTED ON (B)(6) 2025. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.
Patient problems: Deformity/ Disfigurement
MAUDE report 22874409 ↗InjuryMay 14, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT 550CC TISSUE EXPANDER WHEN THE LEFT BREAST DEVICE DEFLATED POST IMPLANTATION. UPON EXPLANTATION, A SMALL OPENING ON THE POSTERIOR EDGE WHERE THE BACK PATCH AND THE SHELL MEET WAS OBSERVED.
Patient problems: Deformity/ Disfigurement
MAUDE report 22022132 ↗MalfunctionDec 2, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT, 450 CC SALINE TISSUE EXPANDER PROSTHESIS EXPERIENCED UNKNOWN SIDED DEFLATION INTRAOPERATIVE. NO PATIENT CONSEQUENCES REPORTED, OR NO ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20826340 ↗MalfunctionNov 12, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT 450CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED DEFLATION INTRAOPERATIVE. THE DEFECTIVE IMPLANT NOT IN CONTACT WITH PATIENT, AND NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20666328 ↗InjurySep 12, 2024Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture
IT WAS REPORTED THAT A 550CC MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT DEFLATED, AND DELAMINATED DEVICE WAS REMOVED ON (B)(6) 2024 AND ACCIDENTALLY DISCARDED. PHOTOS WERE TAKEN. NO OTHER DETAILS ARE AVAILABLE AT THIS TIME. FOLLOW UPS ARE BEING PERFORMED FOR CLARIFICATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE UPDATED AND SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: Deformity/ Disfigurement
MAUDE report 20200222 ↗InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT TISSUE EXPANDERS 450CC AND EXPERIENCED BILATERAL BREAST INFECTIONS POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.
Patient problems: Post Operative Wound Infection
MAUDE report 20147692 ↗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 A BREAST RECONSTRUCTION WITH MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT TISSUE EXPANDERS 450CC AND EXPERIENCED INFECTION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.
Patient problems: Post Operative Wound Infection
MAUDE report 20089236 ↗MalfunctionMar 27, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 350CC MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT TISSUE EXPANDER WAS IDENTIFIED TO HAVE A SMALL LEAK, PRE-IMPLANTATION. THE LEAK IS LOCATED WHERE THE PORT MEETS THE BUFFER ZONE OF THE IMPLANT. THERE WAS REPORTED TO BE A FIFTEEN MINUTE DELAY. A NEW BACKUP EXPANDER WAS IMPLANTED INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18989362 ↗InjuryMar 25, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR CPX4 PLUS, SMOOTH, TALL 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 18975111 ↗MalfunctionJun 7, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT UPON OPENING OF THE DEVICE PACKAGING OF A 550CC MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT TISSUE EXPANDER, THE DEVICE WAS OBSERVED TO BE DEFLATED. THE EVENT OCCURRED PRE-OPERATIVELY, AND THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. THERE WERE NO REPORTED ADVERSE EVENTS OR PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17082889 ↗InjuryMay 31, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH AN UNSPECIFIED BREAST TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. IT WAS STATED THAT AFTER A MONTH, THE TISSUE EXPANDER WAS DEFECTIVE AND LEAKED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. IT WAS UNKNOWN IF THE REPORTED DEVICE WAS A MENTOR DEVICE AND AS SUCH THE COMPLAINT IS BEING REPORTED CONSERVATIVELY. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.
Patient problems: Deformity/ Disfigurement
MAUDE report 17032151 ↗
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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