MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549311Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00081317006770), received between May 9, 2022 and May 20, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS, 250CC BREAST IMPLANT EXPERIENCED LEFT SIDED ¿DEFECTIVE VALVE¿ INTRAOPERATIVELY. THE REPORT INDICATED THAT MOISTURE WAS DETECTED ON THE EDGE OF THE EXPANDER. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14455123 ↗
• MalfunctionMay 9, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT 250CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS WAS PLACED UNDER THE BREAST FLAP, THE FLAP WAS CLOSED, AND THE EXPANDER WAS FILLED. THE EXPANDER WAS PLACED WITH THE FINGERS AND IN THIS MANEUVER THE EXPANDER DEFLATED. AS A RESULT, NEW EXPANDER WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES OR ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336143 ↗

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-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-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