MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549215Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00081317006756), received between Feb 14, 2018 and Jun 26, 2025 — classified as 32 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (27 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 34 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A LEAKING LEFT EXPANDER BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT TISSUE EXPANDER REMOVAL ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22338803 ↗
• InjuryDec 6, 2024Material Rupture; Material Rupture

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

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20865642 ↗
• InjuryJun 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT EXPERIENCED A DEFLATION OF HER LEFT PROSTHESIS, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2024. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19552074 ↗
• InjuryJan 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ON AN UNSPECIFIED BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON AN UNSPECIFIED DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18515600 ↗
• InjuryDec 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO HAD A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS PLACED EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. THE PATIENT NOTED A DECREASE IN SIZE OF SEVERAL MONTHS WHICH EVENTUALLY RESULTED IN WHAT APPEARED TO BE COMPLETE DEFLATION. AS A RESULT, REPLACEMENT WITH A NEW 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS WAS PERFORMED ON (B)(6) 2023. THE PATIENT IS FULLY RECOVERED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18384320 ↗
• InjuryDec 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED A DEFLATION ON AN UNSPECIFIED SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18368408 ↗
• InjuryOct 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION PROCEDURE WITH UNKNOWN SIZE UNKNOWN TISSUE EXPANDERS AND EXPERIENCED EXPANDER DEFLATION AT THE SEAM ON HER RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT REPLACEMENT SURGERY ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17957586 ↗
• InjuryOct 9, 2023Migration; Migration

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED A DEVICE MIGRATION ON AN UNKNOWN SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17901409 ↗
• InjuryAug 1, 2023Material Rupture; Material Rupture

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

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17438753 ↗
• InjuryJul 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 650CC 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) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17417053 ↗
• InjuryJul 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH AN UNSPECIFIED MENTOR TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17398533 ↗
• InjuryMay 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A MED HEIGHT TE W/SUT TABS 650CC AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16994661 ↗
• InjuryFeb 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 28-YEAR-OLD FEMALE WHO UNDERWENT BREAST RECONSTRUCTION WITH 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. THE SEAM ON THE LOWER BORDER OF THE IMPLANT WAS RUPTURED. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2021. SEE 1645337-2023-02240 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16456114 ↗
• InjuryFeb 28, 2023Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A 28-YEAR-OLD FEMALE WHO UNDERWENT BREAST RECONSTRUCTION WITH 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. THE SEAM ON THE LOWER BORDER OF THE IMPLANT WAS RUPTURED. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2021. SEE 1645337-2023-02242 FOR CONTRALATERAL PROSTHESIS REPORT.

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

  MAUDE report 16455235 ↗
• InjuryJan 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION SURGERY WITH IMPLANTATION OF A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST EXPANDER. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON AN UNDISCLOSED DATE. THE DATE OF IMPLANTATION WAS NOT PROVIDED TO MENTOR. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16093589 ↗
• InjuryDec 1, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED VIA A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021. THE TISSUE EXPANDER WAS IN USE FOR LONGER THAN SIX MONTHS, WHICH IS CONSIDERED OFF LABEL USE OF THE PRODUCT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12910866 ↗
• MalfunctionApr 27, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS STARTED LEAKING INTRAOPERATIVELY. AS A RESULT, THE EXPANDER WAS REPLACED WITH A SIMILAR EXPANDER SERIAL NUMBER (B)(4), AND THE PROCEDURE CONTINUED. THERE WERE NO PATIENT CONSEQUENCES OR PROCEDURE DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11735015 ↗
• InjuryMar 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE UNDERWENT BREAST RECONSTRUCTION WITH 650CC MENTOR CPX 4 BREAST TISSUE EXPANDERS WITH SUTURE TABS AND EXPERIENCED A LOCAL REACTION RESULTING FROM DEVICE EXTRUSION ON THE LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED TISSUE EXPANDER ON (B)(6) 2021. THE SERIAL NUMBER OF THE IMPACTED DEVICE IS EITHER (B)(4).

  Patient problems: Local Reaction; Wound Dehiscence

  MAUDE report 11580056 ↗
• InjuryOct 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 650CC DEVICE DEVELOPED AN INFECTION IN ONE OF HER BREASTS. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10708709 ↗
• InjuryNov 14, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED LEFT SIDED DEFLATION DUE TO A TEAR POST PROCEDURE. AS A RESULT, REPLACEMENT WITH ANOTHER 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS WAS PERFORMED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9324888 ↗
• InjurySep 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST PROSTHESIS IMPLANTATION PROCEDURE WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ON THE LEFT SIDE, SUFFERED DEFLATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8996476 ↗
• InjuryJul 17, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 650CC DEVICE THAT DEFLATED AFTER IMPLANTATION. IT WAS REPORTED THAT THE TISSUE EXPANDER DEFLATED DUE TO A LEAK. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN UNSPECIFIED DEVICE ON (B)(6) 2019. THE EXPLANTED TISSUE EXPANDER WAS EXAMINED AND FOUND TO BE LEAKING FROM NEAR THE SUTURE TAB ON ANTERIOR LEFT SIDE OF THE DEVICE.

  Patient problems: No Code Available

  MAUDE report 8799199 ↗
• InjuryJul 16, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 650CC AND EXPERIENCED A DEFLATION ON THE LEFT SIDE WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8795689 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT HAD A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 650CC DEVICE IMPLANTED DURING A MASTECTOMY PROCEDURE. THE PATIENT LATER DEVELOPED AN INFECTION IN HER RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2018.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8597203 ↗
• InjuryApr 22, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 650CC TISSUE EXPANDER AND EXPERIENCED DEFLATION POST PROCEDURE. THE EXPANDER WOULD NOT FILL. AS A RESULT, THE DEVICE WAS REPLACED WITH ANOTHER TISSUE EXPANDER ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8537089 ↗

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