MENTOR CPX 2 Breast Tissue Expander 3546214Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00081317002277), received between Aug 20, 2019 and Aug 20, 2019 — 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.

• InjuryAug 20, 2019Material Rupture; Material Rupture

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR ASR/PSR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A PATIENT WITH UNKNOWN AGE, RACE, AND SEX UNDERWENT UNSPECIFIED BREAST AUGMENTATION WITH A 550CC MENTOR CPX 2 BREAST TISSUE EXPANDER AND WAS PRESENTED WITH UNKNOWN SIDE DEFLATION. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2017.

  Patient problems: No Code Available

  MAUDE report 8912289 ↗