MENTOR CPX4 PLUS, Smooth, Low HeightRecalls & reported problems across all models
Mentor Texas L.P. · 2 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, Low Height model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 1
We found 2 models of MENTOR CPX4 PLUS, Smooth, Low Height by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2021 and Oct 28, 2024 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (4 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, Low 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-1682-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported MENTOR CPX4 PLUS, Smooth, Low Height problems
Device problems
- Material Rupture4
- Connection Problem1
Patient problems
- Deformity/ Disfigurement3
- No Clinical Signs, Symptoms or Conditions1
MENTOR CPX4 PLUS, Smooth, Low Height models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR CPX4 PLUS, Smooth, Low Height SCPX157LHExpander, skin, inflatable1 recall3 reports
- MENTOR CPX4 PLUS, Smooth, Low Height SCPX127LHExpander, skin, inflatable1 report
Recent MENTOR CPX4 PLUS, Smooth, Low Height adverse event reports
The 4 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 28, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR CPX4 PLUS, SMOOTH, LOW HEIGHT TISSUE EXPANDERS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Deformity/ Disfigurement
MAUDE report 20549840 ↗InjuryFeb 14, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 37-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH 650CC MENTOR CPX4 PLUS, SMOOTH, LOW HEIGHT TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024, AND REPLACED WITH ANOTHER TISSUE EXPANDER.
Patient problems: Deformity/ Disfigurement
MAUDE report 18705180 ↗InjurySep 7, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 650CC MENTOR CPX4 PLUS, SMOOTH, LOW HEIGHT TISSUE EXPANDER ON AN UNSPECIFIED BREAST. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.
Patient problems: Deformity/ Disfigurement
MAUDE report 17700988 ↗MalfunctionNov 15, 2021Material Rupture; Connection Problem; Material Rupture; Connection Problem
IT WAS REPORTED THAT A DOCTOR NOTICED THAT THE 350 CPX4 PLUS SMOOTH LOW HEIGHT WAS LEAKING AIR FROM A SLIT. IT NEVER WENT INTO THE PATIENT AND WAS NOTICED ON THE BACK TABLE WHEN HE WAS PREPARING IT. THERE WERE NO PATIENT CONSEQUENCES OR PROCEDURE DELAYS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12813358 ↗
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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