MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549212Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00081317006725), received between Jul 3, 2018 and Sep 30, 2026 — classified as 18 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Migration

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50954114 ↗
• InjurySep 30, 2026Migration

  Patient problems: Deformity/ Disfigurement

  MAUDE report 50954108 ↗
• InjuryOct 15, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23304278 ↗
• MalfunctionSep 11, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS BEING USED IN A BREAST IMPLANTATION PROCEDURE WAS FOUND TO BE DIFFICULT TO INFLATE 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 23031399 ↗
• InjuryOct 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS WAS FOUND TO BE DEFLATED PRIOR TO AN OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY ANY PATIENT.

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

  MAUDE report 20518725 ↗
• InjurySep 11, 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 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A LEFT BREAST HEMATOMA BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2024.

  Patient problems: Hematoma

  MAUDE report 20193679 ↗
• 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 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED LEFT SIDED WOUND INFECTION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Post Operative Wound Infection

  MAUDE report 18956011 ↗
• MalfunctionSep 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS WAS OBSERVED TO HAVE A MATERIAL PUNCTURE DURING A BREAST RECONSTRUCTION SURGERY PRIOR TO BEING IMPLANTED INTO THE PATIENT. NO ADVERSE EVENTS OR PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THE DATE OF EVENT WAS NOT PROVIDED TO MENTOR. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17731507 ↗
• InjuryDec 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST RECONSTRUCTION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS, 350CC SALINE BREAST PROSTHESIS EXPERIENCED AN UNKNOWN-SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REPLACEMENT WITH AN UNSPECIFIED IMPLANT ON AN UNKNOWN DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15990197 ↗
• InjuryDec 15, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. POST-OPERATIVELY, THE PATIENT APPEARED TO HAVE A SHARP EDGE OF ONE IMPLANT PUSHING OUTWARD BENEATH THE SKIN. REINFLATION OF THE DEVICE DID NOT SOLVE THE ABNORMAL APPEARANCE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022. UPON EXPLANTATION, THE DEVICE WAS NOTED TO HAVE FOLDING AND ADHESIONS TO THE CAPSULE. THE DATE OF IMPLANTATION WAS NOT PROVIDED TO MENTOR. THE AFFECTED SIDE OF THE PATIENT WAS NOT PROVIDED. 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: Wrinkling

  MAUDE report 15988670 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST RECONSTRUCTION SURGERY WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS, 350CC SALINE BREAST IMPLANT EXPERIENCED BILATERAL ANISOMASTIA POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: L/ CAT#: 3503754BC, SN#: (B)(4), R/ CAT#: 3503754BC, SN#: (B)(4). ON (B)(6) 2022. THIS REPORT RELATES TO ONE OF THE TWO SIDES. NOTE: THEE DEVICES WERE RECEIVED BY MENTOR WITH SOME DOCUMENTS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14734869 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST RECONSTRUCTION SURGERY WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS, 350CC SALINE BREAST IMPLANT EXPERIENCED BILATERAL ANISOMASTIA POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: L/ CAT#: 3503754BC, SN#: (B)(4), R/ CAT#: 3503754BC, SN#: (B)(4)ON (B)(6) 2022. THIS REPORT RELATES TO ONE OF THE TWO SIDES. NOTE: THEE DEVICES WERE RECEIVED BY MENTOR WITH SOME DOCUMENTS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14734825 ↗
• InjuryApr 5, 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 RECONSTRUCTION PRIMARY WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 350CC AND EXPERIENCED INFECTION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A MENTOR SALINE DEVICE ON (B)(6) 2021.

  Patient problems: Post Operative Wound Infection

  MAUDE report 14015604 ↗
• InjuryFeb 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST AUGMENTATION WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS, 350CC. IMPLANT EXPERIENCED UNKNOWN-SIDED DEFLATION POST PROCEDURE. THE REPORT INDICATED THAT THE LEAKING WAS HAPPENED, DUE TO TWO TORN PARTS BETWEEN 'EXPANDER BUFFER ZONE' AND 'EDGE OF THE SHELL.' IT WAS OBSERVED 2 MONTHS (APPROXIMATELY) AFTER THE FIRST IMPLANTATION. THE PHYSICAL EXAMINATION DIAGNOSED THE ISSUE. AS A RESULT, ON (B)(6) 2022, THE EXISTING ARTIFICIAL BREAST IMPLANT WAS REMOVED, AND A NEW PRODUCT WAS INSERTED. SUCCESSFULLY COMPLETED THE REOPERATION.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13419128 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST SURGERY WITH A 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED AN UNSPECIFIED COMPLICATION POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2021. DATES OF IMPLANT AND EXPLANT HAVE BEEN ESTIMATED BASED ON THE MANUFACTURING DATE OF THE DEVICE AND THE DATE OF RECEIPT AT MENTOR, RESPECTIVELY.

  Patient problems: Insufficient Information

  MAUDE report 11572939 ↗
• MalfunctionOct 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 350CC BEING USED IN A BREAST RECONSTRUCTION PRIMARY WAS FOUND TO BE LEAKING DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. A SHORT PROCEDURAL DELAY (10 MINUTES) WAS REPORTED, BUT THERE WERE REPORTEDLY NO ADVERSE EFFECTS ON THE PATIENT. THE SURGEON USED A SIMILAR BACKUP DEVICE (SERIAL NUMBER (B)(4)) TO COMPLETE THE SURGERY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10706162 ↗
• InjuryJan 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 350CC DEFLATED INTRA-OPERATIVELY DURING BREAST RECONSTRUCTION PRIMARY SURGERY ON (B)(6) 2019. RUPTURE OCCURRED AT THE TIME OF PLACEMENT OF THE EXPANDER IN THE SURGICAL POCKET. AS A RESULT, THE TISSUE EXPANDER WAS REPLACED WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 350CC. THERE WERE NO PROCEDURAL DELAYS OR CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement; Not Applicable

  MAUDE report 9537922 ↗
• InjuryNov 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED LEFT SIDED TISSUE EXPANDER LEAKAGE POST PROCEDURE. THE EXPANDER WAS STATED TO BE LEAKING SLOWLY UNDER PRESSURE. AS A RESULT, THE DEVICE WAS REPLACED WITH ANOTHER 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS.

  Patient problems: No Code Available

  MAUDE report 9373111 ↗
• InjuryMay 16, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. A LEAK WAS NOTED AND CONTINUED ON THE DATE OF IMPLANTATION. THE DEVICE WAS EXPLANTED AND REPLACED THE FOLLOWING DAY, AND THE PHYSICIAN NOTED THE AREA OF LEAKAGE AT THE SITE OF THE SUTURE TABS.

  Patient problems: No Code Available

  MAUDE report 8616914 ↗
• InjuryMar 14, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 350CC DEVICE THAT AFTER EXPLANTATION WAS FOUND TO BE FAULTY. EXPLANTATION DATE IS CURRENTLY UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 8421084 ↗
• InjuryJul 3, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 350CC BREAST PROSTHESIS. DEFLATION OF THE RIGHT BREAST PROSTHESIS WAS DETERMINED. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 375CC GEL BREAST PROSTHESIS ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7659927 ↗

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-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
• 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