Mentor CPX4 with suture tabs, med height, smooth 3509216Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00081317026693), received between Jul 24, 2022 and Jul 24, 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

Recent adverse event reports

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

• InjuryJul 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 34-YEAR-FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH A CPX4 WITH SUTURE TABS MEDIUM HEIGHT SMOOTH EXPANDER EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15090596 ↗