MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549314Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00081317006800), received between Mar 13, 2018 and Feb 27, 2026 — classified as 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (14 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 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.

Recalls naming this device

1. Feb 18, 2026Class IIOpen, Classified

   Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

   Z-1681-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS DEVICE DEVELOPED INFLAMMATION/IRRITATION/SWELLING IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS DEVICE.

  Patient problems: Local Reaction

  MAUDE report 24474583 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED RIGHT SIDED WOUND INFECTION AND EARLY ONSET SEROMA POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024. THIS WAS ACCOMPANIED BY PAIN, FEVER, AND AN 80CC OUTPUT OF SEROUS FLUID.

  Patient problems: Post Operative Wound Infection; Seroma

  MAUDE report 18956193 ↗
• InjuryJan 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 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, EXPLANT WAS PERFORMED ON AN UNKNOWN DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18584347 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 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 AN INFECTION OF THE LEFT BREAST BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BREAST TISSUE EXPANDER REMOVAL ON AN UNDISCLOSED DATE. 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: Post Operative Wound Infection

  MAUDE report 18451700 ↗
• InjuryAug 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 550CC DEVICE THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST TISSUE EXPANDER WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNKNOWN DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17638549 ↗
• InjuryJul 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 550CC DEVICE THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST TISSUE EXPANDER WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17354572 ↗
• InjuryNov 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED A DEFLATION ON AN UNKNOWN SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNSPECIFIED DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15763277 ↗
• InjuryAug 31, 2022Adverse 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 AUGMENTATION WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED A WOUND INFECTION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Post Operative Wound Infection

  MAUDE report 15328639 ↗
• InjuryFeb 22, 2022Off-Label Use; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. POST-OPERATIVELY, THE PATIENT WAS CONCERNED THAT THE TISSUE EXPANDERS HAVE BEEN IMPLANTED FOR TWO YEARS DUE TO DELAYED EXPLANTATION SURGERIES FROM COVID. SHE ALSO STATED SHE WAS EXPERIENCING PAIN IN HER CHEST AREA WHILE GARDENING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. PER THE INSTRUCTIONS FOR USE, MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ARE NOT INTENDED FOR USE OVER 6 MONTHS, AND THUS THIS DEVICE IS USED IN A MANNER INCONSISTENT WITH THE IFU. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-01814 FOR THE CONTRALATERAL EVENT.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 13578791 ↗
• InjuryFeb 22, 2022Off-Label Use; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. POST-OPERATIVELY, THE PATIENT WAS CONCERNED THAT THE TISSUE EXPANDERS HAVE BEEN IMPLANTED FOR TWO YEARS DUE TO DELAYED EXPLANTATION SURGERIES FROM COVID. SHE ALSO STATED SHE WAS EXPERIENCING PAIN IN HER CHEST AREA WHILE GARDENING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. PER THE INSTRUCTIONS FOR USE, MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ARE NOT INTENDED FOR USE OVER 6 MONTHS, AND THUS THIS DEVICE IS USED IN A MANNER INCONSISTENT WITH THE IFU. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-01815 THE CONTRALATERAL EVENT.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 13578789 ↗
• InjuryOct 28, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12716467 ↗
• InjuryMay 14, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED LEFT-SIDED EXPANDER DEFLATION AND SOFT-TISSUE NECROSIS POSTOPERATIVELY. THE TISSUE EXPANDER HAD UNDERGONE SIX SUBSEQUENT FILLS WHEN DEFLATION WAS CONFIRMED BY THE SURGEON. FURTHERMORE, THE PATIENT ALSO SUFFERED PARTIAL SKIN FLAP NECROSIS FOUR DAYS POST-OP AND REQUIRED DEBRIDEMENT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED DEVICE ON (B)(6) 2021.

  Patient problems: Necrosis

  MAUDE report 11829041 ↗
• InjuryJul 17, 2020Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS PLACED EXPERIENCED DEFLATION POST PROCEDURE. ADDITIONALLY, THE DEVICE HAS BEEN IMPLANTED FOR OVER SIX MONTHS. THIS IS OFF LABEL USE OF THE DEVICE. AN EXPLANT IS PLANNED FOR (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10290860 ↗
• InjuryMar 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT OF AN UNKNOWN AGE AND ETHNICITY UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND WAS PRESENTED WITH LEFT SIDE DEFLATION POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER: 3549122; SERIAL NUMBER: (B)(4) ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9865658 ↗
• InjuryMar 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 550CC AND SUFFERED FROM LEFT BREAST IMPLANT DEFLATION . AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9842179 ↗
• MalfunctionDec 2, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON 9/30/2019, DURING A PRIMARY BREAST RECONSTRUCTION, A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS WAS PERFORATED INTRA-OPERATIVELY. AS A RESULT, THE USE OF A REPLACEMENT WAS REQUIRED (250CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS). THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9398693 ↗
• InjuryNov 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION. THE DIAGNOSIS WAS CONFIRMED BY A HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. VERY LIMITED INFORMATION WAS RECEIVED REGARDING THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, THIS FILE WILL BE UPDATED, AND A SUPPLEMENTAL WILL BE SUBMITTED AS APPROPRIATE.

  Patient problems: No Code Available

  MAUDE report 9328992 ↗
• MalfunctionApr 11, 2019Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS DURING A PROCEDURE AND COULD NOT FILL THE DEVICE DURING A PROCEDURE. THIS ISSUE WAS NOT ASSOCIATED WITH AN ADVERSE EVENT TO THE PATIENT. THE PHYSICIAN UTILIZED ANOTHER 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8506907 ↗
• InjuryDec 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 550CC AND EXPERIENCED DEFLATION ON THE LEFT SIDE. DEFLATION WAS CONFIRMED BY PHYSICIAN DURING EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED TISSUE EXPANDER ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8147794 ↗
• InjuryMay 15, 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 BILATERAL MASTECTOMY AND PRIMARY BREAST RECONSTRUCTION WITH MENTOR CPX 4 BREAST TISSUE EXPANDERS WITH SUTURE TABS 550CC. COMPLICATIONS WERE REPORTED POST PROCEDURE. AS A RESULT, THE TISSUE EXPANDERS WERE EXPLANTED FROM THE PATIENT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION ON WHEN THE TISSUE EXPANDERS WERE EXPLANTED. THIS REPORT IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 7516204 ↗
• InjuryMay 15, 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 BILATERAL MASTECTOMY AND PRIMARY BREAST RECONSTRUCTION WITH MENTOR CPX 4 BREAST TISSUE EXPANDERS WITH SUTURE TABS 550CC. COMPLICATIONS WERE REPORTED POST PROCEDURE. AS A RESULT, THE TISSUE EXPANDERS WERE EXPLANTED FROM THE PATIENT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION ON WHEN THE TISSUE EXPANDERS WERE EXPLANTED. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: No Code Available

  MAUDE report 7515624 ↗
• InjuryMar 13, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 550CC DEVICE THAT DEFLATED AFTER IMPLANTATION. DEFLATION WAS DISCOVERED DURING THE SECOND STAGE OF RECONSTRUCTION SURGERY WHEN EXCHANGING THE TISSUE EXPANDER WITH A BREAST IMPLANT. IT WAS NOTED THAT THE BREASTS HAD DIFFERENT SHAPES PREOPERATIVELY DUE TO THE DEFLATION OF THE TISSUE EXPANDER. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR BREAST TISSUE EXPANDER ON (B)(6) 2018. THE PATIENT FULLY RECOVERED AND THERE WAS NO INCREASED LENGTH OF STAY AT THE HOSPITAL DUE TO THIS EVENT. THE EXPLANTED DEVICE WAS DISCARDED.

  Patient problems: No Code Available

  MAUDE report 7335160 ↗

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-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