MENTOR CPX 2 Breast Tissue Expander 3546313Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00081317002321), received between Jul 17, 2018 and Jul 17, 2018 — 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 17, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A SILTEX MENTOR CPX 2 BREAST TISSUE EXPANDER 450 CC AND EXPERIENCED DEFLATION ON THE RIGHT BREAST IMPLANT. THE DEFLATION WAS DIAGNOSED DURING PHYSICAL EXAMINATION. AS A RESULT, PATIENT UNDERWENT REMOVAL OF THE IMPLANT ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7695731 ↗