MENTOR CPX4 with Suture Tabs, Tall Height 3549336Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00081317009757), received between Jan 17, 2018 and Mar 9, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Rupture” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT, CPX4 TH 1445CC, TISSUE EXPANDER IMPLANT EXPERIENCED UNKNOWN-SIDED DEFLATION POSTOPERATIVE. HOLE SEEN INSIDE OF THE EXPANDER AWAY FROM THE THICKER SILICONE PLATE. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16514128 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH A 1445CC MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT AND EXPERIENCED UNKNOWN SIDE UNSPECIFIED ADVERSE EVENT. IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING EXCHANGE OF EXPANDERS FOR IMPLANTS. AS A RESULT, THE EXPANDER WAS EXPLANTED ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 16486351 ↗
• InjuryDec 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT 1445CC AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12969538 ↗
• InjuryJan 17, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR CPX4 SILTEX TALL HEIGHT TISSUE EXPANDER WHERE DEFLATION OCCURRED APPROXIMATELY TWO WEEKS AFTER IMPLANTATION. ADDITIONALLY, THE PATIENT EXPERIENCED CAPSULAR CONTRACTURE (BAKER GRADE I). AS A RESULT, THE TISSUE EXPANDER WAS EXPLANTED AND REPLACED ON (B)(6) 2017. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Contracture

  MAUDE report 7201040 ↗