MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549312Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00081317006787), received between Apr 14, 2022 and Nov 19, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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.

• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 350CC TISSUE EXPANDER DEVELOPED AN INFECTION POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNKNOWN DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23598434 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 350CC TISSUE EXPANDER DEVELOPED AN INFECTION POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNKNOWN DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23598363 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH AN INFECTION OF ONE OF THE BREASTS BY A MEDICAL PROFESSIONAL AFTER SHE WENT SWIMMING IN A POOL. THE AFFECTED SIDE WAS NOT PROVIDED. AS A RESULT, THE PATIENT UNDERWENT TISSUE EXPANDER REMOVAL ON AN UNDISCLOSED DATE. FOLLOW-UPS ARE BEING CONDUCTED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23574301 ↗
• InjuryMar 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 350CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED A DEFLATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21700615 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 350CC DEVICE DEVELOPED AN INFECTION IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNKNOWN DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 14650797 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 350CC DEVICE DEVELOPED AN INFECTION IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNKNOWN DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 14115753 ↗

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