MENTOR CPX 4 Breast Tissue Expander 3548115Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00081317006503), received between Sep 4, 2018 and Sep 4, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Inflation 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2018Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 650CC PROSTHESIS THAT COULD NOT BE INFLATED INTRAOPERATIVELY. AFTER IMPLANTATION OF EXPANDER, THE SURGEON FILLED IT WITH SALINE, HOWEVER THE EXPANDER WOULD NOT INFLATE. SURGEON USED ANOTHER MENTOR CPX 4 BREAST TISSUE EXPANDER 650CC TO COMPLETE THE IMPLANTATION. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7843367 ↗

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