MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549111Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00081317006657), received between May 3, 2018 and Feb 25, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Material Rupture

  IT WAS REPORTED THAT A CUSTOMER RECEIVED A DEFECTIVE MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS TISSUE EXPANDER. THE DEVICE DID NOT HAVE ANY AIR AND APPEARED TO BE COMPLETELY FLAT. THE DEVICE WAS NOT USED IN ANY SURGERY AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447074 ↗
• InjuryJun 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 250CC AND EXPERIENCED A RUPTURE ON THE RIGHT SIDE POST-OPERATIVELY. IT WAS INDICATED, BUT UNCONFIRMED THAT THE DEVICE MAY HAVE BEEN DAMAGED AT THE TIME OF IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10143639 ↗
• InjuryMay 3, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 250CC BREAST PROSTHESIS. THE PATIENT REPORTED THAT THE LEFT BREAST PROSTHESIS HAD DEFLATED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH AN UNKNOWN BREAST PROSTHESIS ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7485210 ↗

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-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
• 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