MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549213Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00081317006732), received between Mar 13, 2018 and Jul 30, 2026 — classified as 39 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (36 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 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Material Rupture

  It was reported that a patient underwent a Breast Reconstruction Revision Surgery with implantation of a 450cc MENTOR CPX 4 Breast Tissue Expander with Suture Tabs. Post-operatively, the patient was diagnosed with a deflated left expander using Ultrasound Imaging. As a result, the patient underwent left-sided exchange with a Mentor tissue expander on June 29, 2026.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50091194 ↗
• MalfunctionDec 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS WAS OBSERVED TO BE PUNCTURED WHEN THE PACKAGE WAS OPENED PRE-OPERATIVELY. NO PATIENT INVOLVEMENT WAS INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851092 ↗
• MalfunctionDec 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS DEFLATED DURING A PRIMARY BREAST RECONSTRUCTION SURGERY. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO ADVERSE EVENTS, PATIENT HARMS, OR PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850815 ↗
• InjuryDec 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23747158 ↗
• InjuryJul 3, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST SURGERY WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS, 450CC SALINE PROSTHESIS EXPERIENCE LEFT SIDED DEFLATION 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 22398861 ↗
• MalfunctionJun 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS RUPTURED PREOPERATIVELY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137017 ↗
• InjuryJun 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22125482 ↗
• MalfunctionMar 14, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS PACKAGE WAS OPENED, AND BUBBLES WERE OBSERVED THE SURFACE OF THE EXPANDER DURING A PRIMARY BREAST RECONSTRUCTION SURGERY PRIOR TO BEING IMPLANTED INTO THE PATIENT. NO ADVERSE EVENTS OR PATIENT CONSEQUENCES WERE REPORTED. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610159 ↗
• InjuryDec 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN UNSPECIFIED MENTOR TISSUE EXPANDER EXPERIENCED A DEFLATION POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20978230 ↗
• InjuryNov 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 40-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED LEFT SIDE EXPANDER DEFLATION. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY WITH UNKNOWN MENTOR DEVICES ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20618139 ↗
• MalfunctionSep 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS WAS FOUND TO BE DEFLATED DURING AN OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20323276 ↗
• InjuryMay 22, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED A FAILURE TO EXPAND ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19375913 ↗
• InjuryApr 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION, BUT A SPECIFIC DATE WAS NOT PROVIDED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19034385 ↗
• InjuryMar 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO HAD A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS PLACED EXPERIENCED LEFT SIDED DEFLATION POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18907270 ↗
• InjuryMar 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO HAD A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS PLACED EXPERIENCED LEFT SIDED DEFLATION POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18891652 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO HAD A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS PLACED EXPERIENCED RIGHT SIDED CAPSULAR CONTRACTURE POST PROCEDURE. THIS WAS DIAGNOSED THROUGH ULTRASOUND. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 18592291 ↗
• InjuryJan 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS, 450CC TISSUE EXPANDER EXPERIENCED UNKNOWN SIDED DEFLATION POSTOPERATIVE. THE LEAKAGE IS NEAR THE SELF-HEALING PORT WHERE SALINE IS SUPPOSED TO BE INJECTED, AND IT IS OBSERVED FROM A VIDEO FROM THE CUSTOMER THAT THERE SEEMS TO BE A HOLE IN THE PRODUCT WHICH IS CAUSING THE LEAKAGE. AS A RESULT PATIENT UNDERWENT REMOVAL ON AN UNSPECIFIED DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18537354 ↗
• InjuryAug 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 71-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED EXPANDER DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED IN THE OFFICE. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ONLY SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT PATIENT'S CONDITION IMPROVED AFTER THE SURGERY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17661956 ↗
• InjuryAug 2, 2023Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED DEVICE MIGRATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CAUSED BY AN MRI. THE TISSUE EXPANDER WAS SIGNIFICANTLY DISPLACED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17443687 ↗
• InjuryMay 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED VIA MW5115214 THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED A DEFLATION AND A WOUND INFECTION ON THE RIGHT SIDE POST-OPERATIVELY. A SIGNIFICANT HOLE WAS REPORTED IN THE TISSUE EXPANDER. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNDISCLOSED DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16921738 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BREAST INFECTION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED IMPLANT ON (B)(6)2023.

  Patient problems: Post Operative Wound Infection

  MAUDE report 16896868 ↗
• MalfunctionJul 27, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING A PRIMARY BREAST RECONSTRUCTION PROCEDURE, A SURGEON WAS ATTEMPTING TO INFLATE A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 450CC DEVICE ON THE RIGHT SIDE, BUT THE TISSUE EXPANDER DID NOT STAY INFLATED. THE DEVICE DID NOT TOUCH THE PATIENT AND WAS NOT IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15115693 ↗
• InjuryJul 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS, 450CC SALINE IMPLANT HAS EXPERIENCED LEFT-SIDED DEFLATION POSTOPERATIVELY. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION. AS A RESULT, UNDERWENT REPLACEMENT WITH CAT#:(B)(4) ; SN#: (B)(4) ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14949687 ↗
• InjuryJan 12, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13239800 ↗
• InjuryDec 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH MENTOR CPX 4, BREAST TISSUE EXPANDER WITH SUTURE TABS, 450CC EXPERIENCED LEFT-SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REPLACEMENT WITH CAT#: 3549313, SN#: (B)(4) ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12910818 ↗

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