MENTOR CPX 4 Breast Tissue Expander 3548213Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00081317006541), received between Sep 17, 2018 and Dec 4, 2025 — classified as 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (17 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ONE 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WAS RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB ON OCTOBER 27, 2025, WITH NO ACCOMPANYING INFORMATION. THE DEVICE COULD NOT BE ASSOCIATED WITH AN EXISTING COMPLAINT. IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHY THIS DEVICE WAS RETURNED TO MENTOR. HOWEVER, THE RETURN OF A PROSTHESIS IS CHARACTERISTIC OF A REMOVAL AND REPLACEMENT SURGERY. AS A RESULT, THIS WILL BE CONSERVATIVELY REPORTED TO FDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23718931 ↗
• InjuryFeb 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER ON THE RIGHT BREAST AND SUFFERED DEFLATION, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICE WAS ANOTHER 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER (CATALOG: 3548213).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18772935 ↗
• InjuryOct 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 450CC DEVICE THAT DEFLATED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNKNOWN DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18044360 ↗
• InjuryOct 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 450CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNKNOWN DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18007013 ↗
• InjuryFeb 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT'S BREAST POCKET BECAME TIGHT DUE TO PREVIOUS RADIO THERAPY AND UNSPECIFIED SURGERY AND IT BECAME CONTRACTED OVER THE EXPANDER. THE EXPANDER FOLDER OVER, WAS ENVELOPED, AND DURING INFLATION WITH A NEEDLE, IT WAS REPORTED TO HAVE BEEN PERFORATED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A 270CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG: SMPX270 LOT: 9493141 SN: (B)(4)) ON (B)(6) 2022.

  Patient problems: Capsular Contracture

  MAUDE report 13595870 ↗
• InjuryFeb 21, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION SURGERY WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A LIKE DEVICE ON (B)(6) 2021. THIS DEVICE WAS IMPLANTED LONGER THAN 6 MONTHS. PER IFU, MENTOR TISSUE EXPANDERS ARE NOT INTENDED TO BE IMPLANTED LONGER THAN 6 MONTHS THEREFORE THE DEVICE IS OFF-LABEL.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13572886 ↗
• MalfunctionJul 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED TO MENTOR THAT THE MENTOR CPX 4 BREAST TISSUE EXPANDER 450CC WAS DEFLATED INTRA-OPERATIVELY. THERE WAS NO ADVERSE EVENT, NO PATIENT CONSEQUENCE, NO PROCEDURE DELAY REPORTED. THE TISSUE EXPANDER WAS REPLACED WITH A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240651 ↗
• InjuryDec 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR CPX 4 BREAST TISSUE EXPANDER BEING USED IN A BREAST SURGERY 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 10970470 ↗
• InjuryOct 31, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER AND EXPERIENCED POSTOPERATIVE LEFT-SIDED RUPTURE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER (CATALOG #: 3548213, SERIAL # : (B)(4)) ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9263961 ↗
• InjuryOct 30, 2019Adverse 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 UNDERWENT AN UNSPECIFIED IMPLANTATION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER. THE DEVICE WAS EXPLANTED ON (B)(6) 2019 FOR UNSPECIFIED REASONS. NO DEVICE ISSUE SUCH AS DEFLATION WAS REPORTED.

  Patient problems: No Code Available

  MAUDE report 9256430 ↗
• InjurySep 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER SALINE IMPLANTS AND EXPERIENCED POSTOPERATIVE BILATERAL DEFLATION. THE DIAGNOSIS WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT ON (B)(6) 2019. THIS REPORT IS FOR THE RIGHT PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 8961636 ↗
• InjurySep 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER SALINE IMPLANTS AND EXPERIENCED POSTOPERATIVE BILATERAL DEFLATION. THE DIAGNOSIS WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT ON (B)(6) 2019. THIS REPORT IS FOR THE LEFT PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 8961632 ↗
• InjuryJul 29, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST REDUCTION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 450CC DEVICE THAT DEFLATED AFTER IMPLANTATION. THE EXPANDER WAS FILLED WITH SALINE WHICH LEAKED OUT OF A HOLE ON THE SIDE OF THE DEVICE NEAR THE PORT WHERE THE SALINE WAS INJECTED INTO. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019. THE EXPLANTED DEVICE WAS DISCARDED AFTER SURGERY.

  Patient problems: No Code Available

  MAUDE report 8837391 ↗
• InjuryJun 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT UNKNOWN BREAST RECONSTRUCTION SURGERY WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER AND WAS PRESENTED WITH LEAKING LEFT SIDE EXPANDER. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8731955 ↗
• InjuryJun 12, 2019Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 450CC. THE TISSUE EXPANDER WAS PUT IN THE PATIENT AND WHEN THE SURGEON WENT TO FILL THE EXPANDER IT WOULD NOT FILL PROPERLY. THE SURGERY WAS DELAYED BY FIVE MINUTES BUT THERE WAS NO REPORT OF THIS CAUSING ANY ISSUE FOR THE PATIENT. THE REPLACEMENT DEVICE WAS IMPLANTED WITHOUT ISSUE ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8692357 ↗
• InjuryMar 8, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH MENTOR CPX 4 BREAST TISSUE EXPANDER 450CC AND EXPERIENCED BILATERAL DEFLATION. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR CPX 4 BREAST TISSUE EXPANDER 550CC ON (B)(6) 2018 ON THE LEFT AND ON (B)(6) 2018 ON THE RIGHT BREASTS. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 8406247 ↗
• InjuryMar 8, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH MENTOR CPX 4 BREAST TISSUE EXPANDER 450CC AND EXPERIENCED BILATERAL DEFLATION. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR CPX 4 BREAST TISSUE EXPANDER 550CC ON (B)(6) 2018 ON THE LEFT AND ON (B)(6) 2018 ON THE RIGHT BREASTS. THIS MEDWATCH IS FOR THE LEFT BREAST IMPLANT.

  Patient problems: No Code Available

  MAUDE report 8406240 ↗
• InjuryMar 8, 2019Adverse 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 PRIMARY BREAST RECONSTRUCTION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 450CC DEVICE AND ACELLULAR DERMAL MATRIX ON (B)(6) 2019 DEVELOPED LEFT SIDE SEROMA AND INFECTION WITH STAPHYLOCOCCUS AUREUS BACTERIA THAT WAS OBSERVED ON (B)(6) 2019. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019. PER REPORTER, THE PATIENT HAD THE EXPANDER REPLACED (DATE OF IMPLANTATION UNKNOWN). THE PATIENT WAS HOSPITALIZED UNTIL (B)(6) 2019 AND WAS REPORTED TO BE IN STABLE CONDITION POST EXPLANTATION. THE DEVICE WAS DISCARDED AND THEREFORE DEVICE ANALYSIS CANNOT BE COMPLETED. THERE WAS NO ISSUE REPORTED WITH LOOK OR FEEL OF THE DEVICE PREOPERATIVELY AND NO KNOWN PROBLEM REPORTED WITH THE PACKAGING. FURTHERMORE, THE SURGEON PLACED THE IMPLANT INTO THE PATIENT. THIS ISSUE IS MOST LIKELY RELATED TO PATIENT'S PRE-EXISTING CONDITION. FURTHERMORE, AN ADERMAL CELLULAR MATRIX WAS PLACED WITH THE IMPLANT, WHICH ALSO HAS THE POTENTIAL TO CAUSE PATIENT INFLAMMATORY REACTION.

  Patient problems: No Code Available; Seroma; Unspecified Infection

  MAUDE report 8406101 ↗
• InjuryOct 24, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH MENTOR CPX 4 BREAST TISSUE EXPANDER 450CC BREAST PROSTHESES. BILATERAL RUPTURE WAS REPORTED. IT WAS ADDED THAT A BAD HORSE ACCIDENT MAY HAVE AFFECTED THE BREAST PROSTHESES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH UNKNOWN BREAST PROSTHESES ON (B)(6) 2018. THIS MEDWATCH FORM IS FOR THE "B" SIDE BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 8002409 ↗
• InjuryOct 24, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH MENTOR CPX 4 BREAST TISSUE EXPANDER 450CC BREAST PROSTHESES. BILATERAL RUPTURE WAS REPORTED. IT WAS ADDED THAT A BAD HORSE ACCIDENT MAY HAVE AFFECTED THE BREAST PROSTHESES. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH UNKNOWN BREAST PROSTHESES ON (B)(6) 2018. THIS MEDWATCH FORM IS FOR THE "A" SIDE BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 8002407 ↗
• InjurySep 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH MENTOR CPX 4 BREAST TISSUE EXPANDER 450CC BREAST PROSTHESIS. INFECTION AND HEMATOMA WERE DETERMINED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018.

  Patient problems: Hematoma; No Code Available; Unspecified Infection

  MAUDE report 7893857 ↗
• InjurySep 17, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR CPX 4 BREAST 450CC TISSUE EXPANDER. DEFLATION ON THE RIGHT BREAST TISSUE EXPANDER WAS DIAGNOSED POST PROCEDURE VIA SELF-EXAMINATION AT HOME. AS A RESULT, THE BREAST TISSUE EXPANDER WAS REMOVED AND REPLACED FROM THE PATIENT ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7882950 ↗

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