MENTOR CPX 4 Breast Tissue Expander 3548215Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00081317006565), received between Nov 9, 2018 and Apr 30, 2024 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO HAD A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER PLACED EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19215803 ↗
• MalfunctionJan 9, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX 4 BREAST, 650CC TISSUE EXPANDER EXPERIENCED UNKNOWN SIDED MISSING COMPONENT POST PROCEDURE. THE DOCTOR NOTICED THE EXPANDER MISSING A GREEN NEEDLE. NO PATIENT CONSEQUENCES OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480701 ↗
• InjuryAug 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST TISSUE EXPANDER BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH AN UNDISCLOSED LEFT-SIDED TISSUE EXPANDER ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17611782 ↗
• InjuryMar 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER EXPERIENCED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16541674 ↗
• InjuryJan 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 650CC DEVICE THE DEFLATED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNKNOWN DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16116166 ↗
• InjurySep 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12523479 ↗
• InjuryNov 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION WITH 650CC MENTOR CPX 4 BREAST TISSUE EXPANDERS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT WITH A SIMILAR PRODUCT ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10840896 ↗
• InjuryNov 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION ACCOMPANIED BY DISCOMFORT POST PROCEDURE. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH AN UNSPECIFIED IMPLANT. THE EXPLANTED SURGEON NOTED A RENT ON THE BACK SIDE OF THE TISSUE EXPANDER.

  Patient problems: No Code Available; Pain

  MAUDE report 10826753 ↗
• InjuryOct 30, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT, WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER ON AN UNSPECIFIED SIDE, SUFFERED DEFLATION, POST-OPERATIVELY. THE DEFLATION WAS DIAGNOSED DURING AN IN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER (CATALOG: 3548215 LOT: 7568876 SN: (B)(4) ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10764001 ↗
• InjurySep 22, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER, SUFFERED DEFLATION, POST-PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION SURGERY ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10570405 ↗
• InjuryFeb 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, "LOCAL SAFETY OF IMMEDIATE RECONSTRUCTION DURING PRIMARY TREATMENT OF BREAST CANCER. DIRECT-TO-IMPLANT VERSUS EXPANDER-BASED SURGERY." A (B)(6) FEMALE PATIENT WHO UNDERWENT EXPANDER-BASED RECONSTRUCTION (EBR) IN TWO STAGES HAS EXPERIENCED SEROMA. OBJECTIVES: THIS STUDY INVESTIGATED THE FACTORS THAT COULD LEAD TO MAJOR OR MINOR COMPLICATIONS AFTER EXPANDER- BASED VERSUS DIRECT-TO-IMPLANT (DTI) RECONSTRUCTION. METHODS: THE STUDIED FACTORS WERE AGE, BODY MASS INDEX (BMI), HYPERTENSION, SMOKING, DIABETES, TYPE OF MASTECTOMY (NIPPLE-SPARING/TOTAL), IMPLANT SIZE, NEOADJUVANT/ADJUVANT CHEMOTHERAPY, AND RADIOTHERAPY. THE STUDY SAMPLE INCLUDED 294 IMMEDIATE RECONSTRUCTIONS OVER 3 YEARS. THE PRIMARY OUTCOME WAS THE INCIDENCE OF COMPLICATIONS, MAJOR OR MINOR DEPENDING ON THE NECESSITY OF REVISION SURGERY. FOR THE DTI POCKET, WE APPLIED A VARIANT OF THE CONVENTIONAL SUBMUSCULAR TECHNIQUE. THE STUDY POPULATION COMPRISED 262 WOMEN UNDERGOING 294 IMMEDIATE RECONSTRUCTIONS AFTER MASTECTOMY (32 BILATERAL CASES) AT (B)(6) FROM DECEMBER 2011 TO JUNE 2014.

  Patient problems: Seroma

  MAUDE report 8335455 ↗
• InjuryNov 9, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 650CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT AND BREAST LUMP ON THE LEFT BREAST IMPLANT. THE PATIENT HAD A CT SCAN DONE BY THE HEALTHCARE PROFESSIONAL THAT SHOWED FLUID LEAKING FROM THE LEFT TISSUE EXPANDER. AS A RESULT, THE PATIENT HAD UNDERGONE EXPLANTATION ON (B)(6) 2018.

  Patient problems: Breast Mass; No Code Available

  MAUDE report 8056206 ↗

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-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
• 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