MENTOR CPX 4 Breast Tissue Expander 3548114Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00081317006497), received between May 30, 2018 and Dec 9, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Rupture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH AN UNSPECIFIED MENTOR TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15955115 ↗
• InjurySep 20, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT OF UNKNOWN AGE WHO UNDERWENT AN UNSPECIFIED BREAST PROSTHESIS IMPLANTATION PROCEDURE WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER, SUFFERED DEFLATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED IMPLANT ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9101136 ↗
• InjuryJun 1, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER ON THE RIGHT SIDE, SUFFERED RUPTURE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN UNKNOWN DEVICE ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8661243 ↗
• InjuryMay 30, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER AND EXPERIENCED DEFLATION POST PROCEDURE. THE FINAL FILL VOLUME OF THE EXPANDER WAS 680CCS. ON (B)(6) 2018, DEFLATION WAS NOTED AND THE EXPANDER WAS REFILLED BY THE PHYSICIAN. TWO DAYS LATER, ON (B)(6) 2018, THE PHYSICIAN OBSERVED THAT DEFLATION RECURRED, MEANING THAT THE ISSUE COULD NOT BE RESOLVED BY REINFLATION. AS A RESULT, UNILATERAL REPLACEMENT WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER (CATALOG #3548114, SERIAL #(B)(4)) WAS PERFORMED ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7554963 ↗

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-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-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