MENTOR CPX 4 Breast Tissue Expander 3548316Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00081317006633), received between May 16, 2019 and May 26, 2022 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AFRICAN AMERICAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 750CC AND EXPERIENCED AN OPEN DRAINING WOUND FISTULA AND SWELLING ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6), 2022.

  Patient problems: Impaired Healing; Local Reaction

  MAUDE report 14519258 ↗
• MalfunctionJun 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 700CC MENTOR CPX 4 BREAST TISSUE EXPANDER WAS DISCOVERED TO BE LEAKING PRIOR PLACEMENT INTO THE PATIENT. THERE WAS NO PROCEDURAL DELAY REPORTED AND A BACK UP IMPLANT WAS USED. NO ADVERSE EVENT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051564 ↗
• InjuryMay 16, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 750CC DEVICE THE DEFLATED AFTER IMPLANTATION. DEFLATION OF THE LEFT SIDE DEVICE WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8618239 ↗

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-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