MENTOR CPX 4 Breast Tissue Expander 3548311Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00081317006589), received between Apr 28, 2023 and Apr 28, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, BY A HEALTH AUTHORITY, THAT A FEMALE PATIENT WHO WAS PREVIOUSLY IMPLANTED WITH A MENTOR TALL HEIGHT TE 250CC ON (B)(6) 2014 WAS DIAGNOSED WITH LEFT-SIDED CD30 POSITIVE AND ALK NEGATIVE BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL). THE PATIENT WAS DIAGNOSED WITH INFILTRATING CARCINOMA OF THE LEFT BREAST IN 2003, WHICH WAS TREATED WITH A LUMPECTOMY, AXILLARY DISSECTION, CHEMOTHERAPY, AND RADIOTHERAPY. IN 2012 THE PATIENT HAD A RECURRENCE OF SBR III INFILTRATING DUCTAL CARCINOMA AND A TOTAL MASTECTOMY WAS PERFORMED. ON (B)(6) 2014 THE PATIENT WAS IMPLANTED WITH A MENTOR TALL HEIGHT TE 250CC (LOT #: 354-8311, SERIAL NUMBER: (B)(6)). ON (B)(6) 2015 THE PATIENT HAD RECONSTRUCTION SURGERY WITH ALLERGAN INSPIRA TSM 275 BREAST IMPLANTS (LOT # 265655719701275). THE PATIENT ALSO HAD ¿LIPOMODELLING¿. BY THE END OF (B)(6) 2022, THE PATIENT PRESENTED WITH AN INCREASE IN BREAST VOLUME AND REDNESS. AS A RESULT, BREAST IMPLANT REMOVAL SURGERY AND CHEMOTHERAPY WERE PERFORMED ON (B)(6) 2022. THE LEFT BREAST CAPSULECTOMY SHOWS CD30+ ALK-. AT THE TIME OF DIAGNOSIS, THE PATIENT HAD APPROXIMATELY SEVEN (7) YEARS SINCE THE MENTOR TALL HEIGHT TISSUE EXPANDER WAS REMO

  Patient problems: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL); Deformity/ Disfigurement

  MAUDE report 16833242 ↗

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