Vantage®, Activit-E 350-23-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862603722), received between May 8, 2025 and Jun 12, 2025 — classified as 2 injuries.

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.

• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION PRIMARY INVOLVING MENTOR SMOOTH ROUND MODERATE PLUS PROFILE, 325CC, SALINE PROSTHESIS EXPERIENCED LEFT-SIDED DEFLATION, AND BILATERAL CAPSULAR CONTRACTURES UNKNOWN GRADE POST-OPERATION. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENTS AS FOLLOW: LEFT: REF: (B)(6), SN: (B)(6), RIGHT: REF: (B)(6), SN: (B)(6), BILATERAL OPEN CAPSULECTOMIES, AND PLACEMENT OF MESH ON (B)(6), 2025. THIS REPORT RELATES TO THE RIGHT SIDE.

  Patient problems: Capsular Contracture

  MAUDE report 22197742 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION PRIMARY INVOLVING MENTOR SMOOTH ROUND MODERATE PLUS PROFILE, 325CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED LOCAL REACTION AND PARESTHESIA POST-OPERATION. THE PATIENT REPORTED THE RIGHT SIDED SWELLING AND BURNING. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Local Reaction; Paresthesia

  MAUDE report 21988104 ↗