MENTOR CPX 4 Breast Tissue Expander 3548216Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00081317006572), received between Oct 19, 2018 and May 5, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K130813); they may or may not involve this specific model.

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.

• InjuryMay 5, 2021Migration; Migration

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR CPX 4 BREAST TISSUE EXPANDERS 800CC AND EXPERIENCED BILATERAL DEVICE MIGRATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR SALINE BREAST IMPLANTS (SERIAL NUMBERS (B)(4)) ON (B)(6) 2016. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11777731 ↗
• InjuryMay 5, 2021Off-Label Use; Migration; Off-Label Use; Migration

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR CPX 4 BREAST TISSUE EXPANDERS 800CC AND EXPERIENCED BILATERAL DEVICE MIGRATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR SALINE BREAST IMPLANTS (SERIAL NUMBERS (B)(4)) ON (B)(6) 2016. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS. PER THE IFU, THIS DEVICE WAS USED IN AN OFF-LABEL MANNER. THIS DEVICE IS NOT INTENDED FOR USE BEYOND SIX MONTHS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11777730 ↗
• InjuryOct 19, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH MENTOR CPX 4 BREAST TISSUE EXPANDER 800CC BREAST PROSTHESES. WHEN THE EXPANDERS WERE BEING REPLACED WITH PERMANENT IMPLANTS, IT WAS DISCOVERED BY THE PATIENT'S DOCTOR THAT THE TISSUE EXPANDERS HAD DEFLATED ON BOTH THE RIGHT AND LEFT SIDE. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 7987089 ↗
• InjuryOct 19, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH MENTOR CPX 4 BREAST TISSUE EXPANDER 800CC BREAST PROSTHESES. WHEN THE EXPANDERS WERE BEING REPLACED WITH PERMANENT IMPLANTS, IT WAS DISCOVERED BY THE PATIENT'S DOCTOR THAT THE TISSUE EXPANDERS HAD DEFLATED ON BOTH THE RIGHT AND LEFT SIDE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 7987087 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130813. One submission often covers many models, so check the product and lot details in each record.

• Z-1681-2026 · Feb 18, 2026 · Open, Classified
  CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
• Z-2748-2016 · Aug 9, 2016 · Terminated
  MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy
• Z-2781-2016 · Aug 9, 2016 · Terminated
  CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision
• Z-2747-2016 · Aug 9, 2016 · Terminated
  MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy