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MENTOR CPX4 PLUS, Smooth, Tall Height SCPX146THRecalls & reported problems

Mentor Texas L.P. · Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 750CC · Class U · Implant

All models of MENTOR CPX4 PLUS, Smooth, Tall Height (5)

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 10081317028465), received between Mar 11, 2022 and Mar 11, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Rupture” (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.

Most reported problems

Device problems

  • Material Rupture1

Patient problems

  • Deformity/ Disfigurement1

Recent adverse event reports

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

  • InjuryMar 11, 2022Material Rupture; Material Rupture

    IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR CPX4 PLUS SMOOTH TALL HEIGHT 750CC BREAST IMPLANT EXPERIENCED UNKNOWN- SIDED DEFLATED POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REPLACEMENT WITH CAT#: (B)(4), SN#: (B)(4) ON (B)(6) 2022.

    Patient problems: Deformity/ Disfigurement

    MAUDE report 13739055 ↗

Other Expander, skin, inflatable devices

All Expander, skin, inflatable devices →

Sources and updates

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