MENTOR CPX 4 Breast Tissue Expander 3548315Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00081317006626), received between Jul 10, 2019 and Jun 6, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER AND EXPERIENCED DEFLATION ON AN UNKNOWN SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17075356 ↗
• InjuryMar 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH AN 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON AN UNKNOWN SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16499003 ↗
• InjuryOct 6, 2021Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION SURGERY WITH MENTOR CPX 4 BREAST 650 CC TISSUE EXPANDER EXPERIENCED UNKNOWN SIDED DEFLATED POST PROCEDURE. AS A RESULT, THE EXPANDER WAS EXPLANTED ON AN UNKNOWN DATE, AND EXPLANTED EXPANDER FOUND TO HAVE A TEAR IN THE BACK PAD.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12586518 ↗
• MalfunctionFeb 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER SPONTANEOUSLY DEFLATED INTRA-OPERATIVELY DURING A PRIMARY BREAST RECONSTRUCTION. THE TISSUE EXPANDER WAS NOTICED TO BE LEAKING WHEN THE DOCTOR WAS CLOSING UP THE PATIENT. AS A RESULT, A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER (CATALOG: 3548215 LOT: 9476755 SN: (B)(4)) WAS UTILIZED AND IMPLANTED. NO PATIENT CONSEQUENCE OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11297922 ↗
• InjuryDec 5, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 650CC AND EXPERIENCED DEFLATION ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 650CC, CATALOG NUMBER: 3548315, SERIAL NUMBER: (B)(4) ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9419243 ↗
• InjuryJul 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 350CC AND EXPERIENCED DEFLATION POST-OPERATIONAL. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8777224 ↗

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-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