MENTOR CPX 3 Breast Tissue Expander with Suturing Tabs 3547215Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00081317003700), received between Nov 9, 2021 and Nov 9, 2021 — 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.

• InjuryNov 9, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD AFRICAN AMERICAN FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX 3 BREAST TISSUE EXPANDER WITH SUTURING TABS 650CC DEVICE THAT DEFLATED POST IMPLANTATION. IT WAS REPORTED THAT ONE OF THE PATIENT¿S BREASTS IS SMALLER THAN THE OTHER AS WELL AS ITCHING UNDERNEATH THE LEFT BREAST. THE PATIENT ALSO DEVELOPED MIGRAINES AND SWELLING ON THE BACK. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE SUSPECT MEDICAL DEVICE HAS BEEN IMPLANTED IN THE PATIENT FOR LONGER THAN SIX MONTHS WHICH GOES AGAINST THE PRODUCT¿S IFU.

  Patient problems: Local Reaction

  MAUDE report 12783502 ↗