MENTOR CPX 3 Breast Tissue Expander with Suturing Tabs 3547213Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00081317003687), received between Mar 30, 2020 and Mar 30, 2020 — 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.

• InjuryMar 30, 2020Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR CPX 3 BREAST TISSUE EXPANDER WITH SUTURING TABS 450CC DEVICE THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT TISSUE EXPANDER WAS REPORTED. THE DEVICE WAS IMPLANTED IN THE PATIENT FOR LONGER THAN 6 MONTHS, WHICH IS AGAINST THE IFU. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 9900500 ↗