MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549317Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00081317006831), received between Oct 15, 2020 and Feb 20, 2025 — classified as 3 injuries.

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.

• InjuryFeb 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF A 850CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A LEAKING LEFT BREAST TISSUE EXPANDER DURING A PHYSICAL EXAM WITH A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT BREAST TISSUE EXPANDER REMOVAL ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21423359 ↗
• InjuryNov 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT AN ASIAN FEMALE WHO UNDERWENT BREAST RECONSTRUCTION WITH AN 850CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, REPLACEMENT WITH A 685CC MENTOR MEMORYSHAPE BREAST IMPLANT WAS PERFORMED ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15844438 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS ASSOCIATED WITH THE ATHENA CLINICAL TRIAL. IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION PRIMARY SURGERY WITH MENTOR ATHENA STUDY GEL DEVICES ON (B)(6) 2017. ADVERSE EVENT NUMBER 1. (B)(4) IMPLANT PALPABILITY/VISIBILITY, (RIGHT SIDE, IMPLANT SERIAL NUMBER: (B)(4). DATE OF IMPLANT: (B)(6) 2017, DATE OF EXPLANT: (B)(6) 2017). ON 05/15/2017, SHE PRESENTED WITH IMPLANT PALPABILITY/VISIBILITY, WHICH REQUIRED INCISION/DRAINAGE/ASPIRATION AND SKIN ADJUSTMENT. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS SEVERE IN SEVERITY, NON-SERIOUS, PROBABLY RELATED TO THE DEVICE, AND POSSIBLY RELATED TO THE PROCEDURE. ADVERSE EVENT NUMBER 2. (B)(4) SEROMA, (RIGHT SIDE, IMPLANT SERIAL NUMBER: (B)(4). DATE OF IMPLANT: (B)(6) 2017, DATE OF EXPLANT: (B)(6) 2017). ON (B)(6) 2017, SHE PRESENTED WITH SEROMA, WHICH REQUIRED UNKNOWN INTERVENTION. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, NON-SERIOUS, POSSIBLY RELATED TO THE DEVICE, AND POSSIBLY RELATED TO THE PROCEDURE. ADVERSE EVENT NUMBER 3. (B)(4) CELLULITIS, (RIGHT SIDE, IMPLANT SERIAL NUMBER: (B)(4). DATE OF IMPLANT: (B)(6) 2017, DATE OF EXPLANT: (B)(6) 2017). ON

  Patient problems: No Code Available; Seroma

  MAUDE report 10687481 ↗

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