MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549113Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00081317006671), received between Sep 25, 2018 and May 21, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. POST-OPERATIVELY, BOTH EXPANDERS HAD LEAKED TWICE, AND ULTIMATELY, THE EXPANDERS DEFLATED REQUIRING A REFILLING WITH SALINE SOLUTION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION 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: Deformity/ Disfigurement

  MAUDE report 22065038 ↗
• InjuryMay 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. POST-OPERATIVELY, BOTH EXPANDERS HAD LEAKED TWICE, AND ULTIMATELY, THE EXPANDERS DEFLATED REQUIRING A REFILLING WITH SALINE SOLUTION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION 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: Deformity/ Disfigurement

  MAUDE report 22064816 ↗
• InjuryMay 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO HAD A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS PLACED EXPERIENCED RIGHT SIDED BAKER GRADE IV CAPSULAR CONTRACTURE AND RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Capsular Contracture

  MAUDE report 19323988 ↗
• MalfunctionApr 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS BEING USED IN A PRIMARY BREAST RECONSTRUCTION WAS DEFLATED DURING THE OPERATION. THE EXPANDER WAS CUT BY ACCIDENT WITH SCISSORS WHILE MANIPULATING THE EXPANDER 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 16773206 ↗
• MalfunctionJun 14, 2021Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995424 ↗
• InjuryFeb 28, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT OF UNKNOWN AGE UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A SALINE MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 450CC AND EXPERIENCED DEFLATION ON UNKNOWN SIDE BREAST IMPLANT. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A NEW TISSUE EXPANDER OF UNKNOWN TYPE ON UNKNOWN DATE.

  Patient problems: No Code Available

  MAUDE report 8378652 ↗
• InjurySep 25, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT HAD A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TAB INSERTED. THE DAY AFTER THE EXPANDER WAS FILLED WITH AN ADDITIONAL 50CCS SHE BEGAN TO NOT FEEL RIGHT. ULTRASOUND AND COMPUTED TOMOGRAPHY WAS PERFORMED AND REVEALED A RIGHT SIDED DEFLATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE, HOWEVER, FUTURE EXPLANTATION IS INDICATED.

  Patient problems: No Code Available

  MAUDE report 7908009 ↗

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-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