MENTOR CPX 2 Breast Tissue Expander 3546215Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00081317002284), received between Aug 28, 2019 and Feb 7, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Rupture” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A 650CC MENTOR CPX 2 BREAST TISSUE EXPANDER EXPERIENCED LEFT SIDED RUPTURE ACCOMPANIED BY DISFIGUREMENT POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18664599 ↗
• InjuryJun 16, 2022Material Rupture; Use of Device Problem; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 650CC MENTOR CPX 2 BREAST TISSUE EXPANDER ON BOTH SIDES AND EXPERIENCED BILATERAL DEFLATION, AND BILATERAL BREAST MASS POSTOPERATIVELY. THE PATIENT ALSO WANTED VERIFICATION ON THE UPCOMING KNEE SURGERY, AND TO FIND OUT IF EXPANDERS ARE MRI COMPATIBLE. THE PATIENT HAS CONSULTED WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

  Patient problems: Breast Mass

  MAUDE report 14719432 ↗
• InjuryJun 16, 2022Material Rupture; Use of Device Problem; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH 650CC MENTOR CPX 2 BREAST TISSUE EXPANDER ON BOTH SIDES AND EXPERIENCED BILATERAL DEFLATION, AND BILATERAL BREAST MASS POSTOPERATIVELY. THE PATIENT ALSO WANTED VERIFICATION ON THE UPCOMING KNEE SURGERY, AND TO FIND OUT IF EXPANDERS ARE MRI COMPATIBLE. THE PATIENT HAS CONSULTED WITH A MEDICAL PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT-SIDED DEVICE.

  Patient problems: Breast Mass

  MAUDE report 14719272 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR OLD FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX 2 BREAST TISSUE EXPANDER ON THE RIGHT SIDE, SUFFERED LARGE AMOUNT OF SEROMA POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A MENTOR GEL IMPLANT ON (B)(6) 2017. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR ASR/PSR REFERENCE NUMBER (B)(4).

  Patient problems: No Code Available; Seroma

  MAUDE report 8941359 ↗