MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549214Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00081317006749), received between Mar 30, 2018 and May 21, 2026 — classified as 50 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (45 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 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Material Rupture

  IT WAS REPORTED THAT A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS BEING USED IN A BREAST AUGMENTATION PROCEDURE WOULD NOT STAY FILLED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED A BACKUP DEVICE AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244063 ↗
• InjuryMar 9, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24552168 ↗
• InjuryMar 6, 2026Material Rupture

  A FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 550CC, SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POSTOPERATIVELY. THE ISSUE WAS CONFIRMED THROUGH MRI EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REPLACEMENT WITH LEFT: SN (B)(6) / CAT: 3549214 ON (B)(6), 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24532717 ↗
• InjuryJun 11, 2025Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR CPX 4 BREAST TISSUE EXPANDERS WITH SUTURE TABS AND EXPERIENCED BILATERAL DEFLATION POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025. THE IMPACTED PRODUCT IN THIS COMPLAINT IS INTENDED FOR TEMPORARY SUBCUTANEOUS OR SUBMUSCULAR IMPLANTATION AND IS NOT INTENDED FOR USE BEYOND SIX MONTHS. THE REPORTED IMPLANTATION/EXPLANTATION DATES SUGGESTS AN OFF-LABEL USE OF THE DEVICE. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22183846 ↗
• InjuryMar 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 550CC AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A MENTOR GEL BREAST IMPLANT ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21644626 ↗
• MalfunctionOct 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION SURGERY. WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS, 550CC SALINE PROSTHESIS EXPERIENCED UNKNOWN SIDED DEFLATION INTRAOPERATIVE. THE SURGEON IS ABOUT TO INSERT THE TISSUE EXPANDER TO PATIENT. SURGEON CONDUCT CHECKING TO TISSUE EXPANDER PRIOR INSERTION. UPON CHECKING SURGEON NOTICE THAT THERE¿S A CRACK CAUSING A LEAKAGE AT THE SIDE OF THE PORT (NOT THE POINT OF NEEDLE INSERTION). NO HARM TO THE PATIENT OR DELAYED TO THE OPERATION WAS OBSERVED.,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20546777 ↗
• InjuryOct 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS, 550CC SALINE PROSTHESIS EXPERIENCED LEFT-SIDED DEFLATION POST OPERATION. THE ISSUE WAS DIAGNOSED THROUGH PATIENTS' SYMPTOM, PALPATION, VISUAL, AND FEEL EXAMINATION. AS A RESULT, PATIENT UNDERWENT REPLACEMENT WITH MENTOR SALINE TISSUE EXPANDER CAT: 3549214 ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20348258 ↗
• InjuryMar 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED EXPANDER DEFLATION ON HER RIGHT SIDE. EXPANDER WAS FOUND TO BE TORN AT THE JUNCTION BETWEEN THE INFERIOR TAB AND THE EXPANDER. AS A RESULT, THE EXPANDER WAS EXPLANTED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18932701 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE 3-4) ON AN UNKNOWN SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Capsular Contracture

  MAUDE report 18852870 ↗
• InjuryFeb 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ON THE RIGHT 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 18673552 ↗
• MalfunctionJun 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS BEING USED IN A BREAST RECONSTRUCTION WAS FOUND TO BE DEFLATED DURING THE 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 17088001 ↗
• InjuryApr 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST TISSUE EXPANDER BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON AN UNDISCLOSED DATE. THE DATE OF IMPLANTATION WAS NOT PROVIDED TO MENTOR. 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: Deformity/ Disfigurement

  MAUDE report 16695521 ↗
• InjuryApr 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 52-YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS, 550CC SALINE TISSUE EXPANDER EXPERIENCED RIGHT-SIDED DEFLATION INTRAOPERATIVELY. THE ISSUE WAS DIAGNOSED THROUGH PHYSICAL EXAMINATION DURING SURGERY. THE EXPANDER WAS IMPLANTED, AND TISSUE WAS CLOSED, THE EXPANDER APPEARED TO BE DEFLATING, SO THE PATIENT WAS RE-OPENED, AND A NEW EXPANDER WITH CATALOG 3549214, SERIAL NUMBER (B)(4) WAS PLACED ON (B)(6) 2023. THE SURGERY WAS PROLONGED.

  Patient problems: Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16668334 ↗
• InjuryMar 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 61-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 550CC 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 16468871 ↗
• InjuryJan 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, AN EXPLANT WAS PERFORMED ON AN UNKNOWN DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16098669 ↗
• InjuryJan 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT BREAST EXPANDER. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON AN UNDISCLOSED DATE. THE DATE OF IMPLANTATION WAS NOT PROVIDED TO MENTOR. 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: Deformity/ Disfigurement

  MAUDE report 16093618 ↗
• InjuryDec 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH AN UNSPECIFIED TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. IT WAS UNKNOWN IF THE REPORTED DEVICE WAS A MENTOR DEVICE AND AS SUCH THE COMPLAINT IS BEING REPORTED CONSERVATIVELY. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16030305 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT WHO UNDERWENT AN BREAST AUGMENTATION PRIMARY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS, 550CC ON THE LEFT, AND MENTOR MEMORYSHAPE 515CC SILICONE BREAST IMPLANT ON THE RIGHT SIDE HAS EXPERIENCED BILATERAL BREAST PAIN POSTOPERATIVE. PATIENT HAS NOT YET BEEN INTO OFFICE FOR EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT RELATES TO THE LEFT PROSTHESIS

  Patient problems: Breast Discomfort/Pain

  MAUDE report 15771856 ↗
• InjuryJul 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 54-YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 550CC DEVICE DEVELOPED AN INFECTION IN HER RIGHT BREAST POST IMPLANTATION. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE DEFLATED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION WITH NO REPLACEMENT DEVICE ON (B)(6) 2022.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15006687 ↗
• InjuryJun 23, 2022Material Rupture; Use of Device Problem; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A 41-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14793157 ↗
• InjuryJun 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 550CC MENTOR CPX 4 BREAST TISSUE EXPANDERS WITH SUTURE TABS AND EXPERIENCED BILATERAL DEFLATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT EXPLANTATION ON AN UNDISCLOSED DATE. THIS REPORT IS FOR THE SIDE B DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14633906 ↗
• InjuryJun 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 550CC MENTOR CPX 4 BREAST TISSUE EXPANDERS WITH SUTURE TABS AND EXPERIENCED BILATERAL DEFLATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT EXPLANTATION ON AN UNDISCLOSED DATE. THIS REPORT IS FOR THE SIDE A DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14633868 ↗
• InjuryApr 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST REVISION WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ON AN UNSPECIFIED BREAST. POST-OPERATIVELY, THE PATIENT EXPERIENCED BREAST IMPLANT TEAR. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON AN UNSPECIFIED DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14092775 ↗
• InjuryMar 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS, 550CC BREAST IMPLANT EXPERIENCED RIGHT-SIDED DEFLATION POST PROCEDURE. AT THE TIME OF DEFLATION DEVICE WAS FILLED UP TO 180CC. AS A RESULT, PATIENT UNDERWENT UNILATERAL REPLACEMENT WITH CAT#: 3549214, SN#:(B)(4) ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13826130 ↗
• InjuryMar 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 550CC AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2020.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13803995 ↗

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