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MENTOR CPX4 PLUS Enhance, Smooth, Tall Height SCPX15THERecalls & reported problems

Mentor Texas L.P. · Breast Tissue Expander, Suture Tabs, Integral Injection Dome · Class U · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10081317032332), received between Feb 18, 2026 and Feb 18, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (1 report).

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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Migration1

Patient problems

  • Skin Inflammation/ Irritation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 18, 2026Migration

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 1445CC MENTOR CPX4 PLUS ENHANCE, SMOOTH, TALL HEIGHT TISSUE EXPANDER AND EXPERIENCED A SKIN REACTION AND DEVICE MIGRATION ON THE LEFT SIDE POST-OPERATIVELY. THE TISSUE EXPANDER HAD ¿TURNED OVER¿ AND WAS UPSIDE DOWN. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED A RASH. THE PATIENT IS APPLYING 1% CORTISONE CREAM TWICE A DAY WITH NO IMPROVEMENT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Patient problems: Skin Inflammation/ Irritation

    MAUDE report 24379717 ↗

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Sources and updates

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