G7® Freedom® Vivacit-E® 30203608Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024588431), received between Mar 3, 2023 and Mar 3, 2023 — classified as 1 death.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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.

• DeathMar 3, 2023Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LINER WOULD NOT SEAT PROPERLY. A DELAY OCCURRED THAT REQUIRED THE SURGEON TO CEMENT IN THE PATIENT AND SPEND AN EXTRA 20 (TWENTY) MINUTES. THE PATIENT CODED WHEN CEMENTING THE FEMUR AND EXPIRED DUE TO PE (PULMONARY EMBOLISM). ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pulmonary Embolism

  MAUDE report 16477277 ↗