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SAVI® 00884450434239Recalls & reported problems

Merit Medical Systems, Inc. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450434239), received between Mar 31, 2021 and Mar 31, 2021 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Hemorrhage/Blood Loss/Bleeding1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE ACCOUNT ALLEGES THAT WHILE PLACED THE SAVI WITH A TROCAR, THE PATIENT EXPERIENCED SIGNIFICANT BLEEDING. THE PROCEDURE HAS TO BE STOPPED AND THE SAVI WAS NOT PLACED. NO PATIENT HARM TO REPORT AND THE BLEEDING HAS BEEN STOPPED.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 11596293 ↗

Other System, applicator, radionuclide, remote-controlled devices

All System, applicator, radionuclide, remote-controlled devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.