MENTOR CPX 4 Breast Tissue Expander 3548313Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00081317006602), received between Feb 27, 2019 and Jan 25, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Rupture” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER, 450CC, SALINE PROSTHESIS EXPERIENCED RIGHT-SIDED DEFLATION POST PROCEDURE. THE REPORT STATED THAT THE MENTOR TISSUE EXPANDER HAD BROKEN AT THE SEAM AND NEEDED TO BE EXPLANTED AND A BREAST IMPLANT IMPLANTED. AS A RESULT, PATIENT UNDERWENT REPLACEMENT WITH AN UNSPECIFIED IMPLANT ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16242294 ↗
• InjuryFeb 27, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER AND EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. THE PHYSICIAN NOTED A RENT AT THE JUNCTURE OF THE PORT AND THE INTERFACE. THE PATIENT HAD DEVICE REPLACEMENT AS A RESULT. THE PATIENT WAS NOTED TO HAVE RECOVERED PHYSICALLY FROM THE EVENT.

  Patient problems: No Code Available

  MAUDE report 8376039 ↗

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-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
• 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