MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549112Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00081317006664), received between Mar 30, 2018 and Jul 11, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Material Rupture” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION WITH A 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ON AN UNSPECIFIED BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED BREAST IMPLANT DEFLATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19726001 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH A 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED EARLY ONSET SEROMA POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2022.

  Patient problems: Seroma

  MAUDE report 15280373 ↗
• InjuryFeb 11, 2020Off-Label Use; Migration; Off-Label Use; Migration

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. ITCHINESS THROUGHOUT HER ENTIRE BODY AND A REDUCTION IN THE ACTIVENESS OF THE PATIENT WAS NOTED. THE BREASTS WERE DESCRIBED AS DEFORMED, WITH THE LEFT DIFFERING IN APPEARANCE IN AN UNSPECIFIED MANNER. ADDITIONALLY, THE BREASTS WERE SAID TO MOVE AROUND WHEN THE PATIENT WOULD TURN ON HER SIDE. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2020-02143 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: No Code Available

  MAUDE report 9694316 ↗
• InjuryFeb 11, 2020Off-Label Use; Migration; Off-Label Use; Migration

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION WITH 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. ITCHINESS THROUGHOUT HER ENTIRE BODY AND A REDUCTION IN THE ACTIVENESS OF THE PATIENT WAS NOTED. THE BREASTS WERE DESCRIBED AS DEFORMED, WITH THE LEFT DIFFERING IN APPEARANCE IN AN UNSPECIFIED MANNER. ADDITIONALLY, THE BREASTS WERE SAID TO MOVE AROUND WHEN THE PATIENT WOULD TURN ON HER SIDE. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2020-02143 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: No Code Available

  MAUDE report 9694315 ↗
• InjurySep 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED SPONTANEOUS LEFT SIDED DEFLATION POST PROCEDURE. THE DEFLATION WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH 495CC MENTOR MEMORYSHAPE BREAST IMPLANTS WAS PERFORMED.

  Patient problems: No Code Available

  MAUDE report 9082951 ↗
• InjuryNov 13, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 350CC WITH SUTURE TABS EXPERIENCED DEFLATION ON THE RIGHT BREAST TISSUE EXPANDER POST PROCEDURE, CONFIRMED AT OFFICE VISIT. AS A RESULT, THE BREAST PROSTHESIS WAS EXPLANTED FROM THE PATIENT ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8065407 ↗
• InjuryMar 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. INITIALLY CURRENT EVENT WAS COVERED IN MWR-02032018-0000066025. ADDITIONAL INFORMATION WAS RECEIVED FROM AUTHOR ON 03/02/2018. DETAILS OF 7 PATIENTS WERE PROVIDED, THEREFORE CURRENT REPORT IS TO REPORT COMPLICATION OF PATIENT #3, OTHER 6 PATIENTS ARE SUBMITTED TO FDA SEPARATELY. IT WAS REPORTED THAT PATIENT #3 IN THE POST INTERVENTION GROUP UNDERWENT BREAST RECONSTRUCTION SURGERY AND SUFFERED INFECTION RESULTING IN EXPLANTATION. INFECTIONS OCCURRED WITHIN THE FIRST 6 WEEKS FOLLOWING SURGERY. MENTOR DEVICE WITH CATALOG 354-9112, LOT 6768598 WAS USED. DATE OF INFECTION WAS (B)(6) 2013. INFECTION WAS PROCEDURE RELATED, NO BODY IMPAIRMENT WAS INVOLVED. PATIENT REQUIRED HOSPITALIZATION, SURGERY, ANTIBIOTICS AND FULLY RECOVERED. TITLE: ¿ABSORBABLE ANTIBIOTIC BEADS PROPHYLAXIS IN IMMEDIATE BREAST RECONSTRUCTION.¿ THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFECTS OF THIS PROTOCOL MODIFICATION ON PERIPROSTHETIC INFECTION RATES THAT RESULTED IN EXPLANTATION OF THE EXPANDER. THE STUDY WAS CONDUCTED FROM DEC 2012 TO JUNE 2016.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7385579 ↗

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-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
• 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