MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549115Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00081317006695), received between Jun 4, 2021 and May 25, 2023 — 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.

• MalfunctionMay 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS BEING USED IN A PRIMARY BREAST RECONSTRUCTION WAS PUNCTURED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT AND NO PATIENT CONSEQUENCES OR PROCEDURAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17005551 ↗
• InjuryOct 26, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 650CC DEVICE THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST TISSUE EXPANDER WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH 800CC TISSUE EXPANDERS ON (B)(6) 2021. THE SUSPECT MEDICAL DEVICE WAS IMPLANTED IN THE PATIENT FOR LONGER THAN SIX MONTHS. PER THE IFU, TISSUE EXPANDERS ARE TO BE IMPLANTED FOR NO MORE THAN 6 MONTHS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12701299 ↗
• InjuryJun 4, 2021Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT, WHO'S UNDERGONE BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ON THE LEFT BREAST, SUFFERED PERSISTENT HIGH OUTPUT OF ACUTE INFLAMMATORY LYMPHATIC SECRETION, POST-PROCEDURE. THE PERSISTENT SEROMA HAS REQUIRED PUNCTURE DRAINAGE ONE TO TWO THREE TIMES A WEEK. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Seroma

  MAUDE report 11942724 ↗

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