MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549116Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00081317006701), received between Jul 21, 2020 and Jul 21, 2020 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2020Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 750 CC DEVICES THAT BILATERALLY DEFLATED AFTER IMPLANTATION. A SURGEON NOTICED A DISCREPANCY IN SIZE BETWEEN THE TISSUE EXPANDERS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH (B)(6) BREAST PROSTHESES ON (B)(6) 2020. DURING EXPLANTATION SURGERY, FLUID WAS COMING OUT OF BOTH DEVICES. THE TISSUE EXPANDERS WERE IMPLANTED IN THE PATIENT FOR LONGER THAN 6 MONTHS, WHICH IS CONTRAINDICATED IN THE IFU. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT TISSUE EXPANDER.

  Patient problems: No Code Available

  MAUDE report 10303515 ↗
• InjuryJul 21, 2020Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 750CC DEVICES THAT BILATERALLY DEFLATED AFTER IMPLANTATION. A SURGEON NOTICED A DISCREPANCY IN SIZE BETWEEN THE TISSUE EXPANDERS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH NATRELLE BREAST PROSTHESES ON (B)(6) 2020. DURING EXPLANTATION SURGERY, FLUID WAS COMING OUT OF BOTH DEVICES. THE TISSUE EXPANDERS WERE IMPLANTED IN THE PATIENT FOR LONGER THAN 6 MONTHS, WHICH IS CONTRAINDICATED IN THE IFU. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT TISSUE EXPANDER.

  Patient problems: No Code Available

  MAUDE report 10303502 ↗

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-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
• 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