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FREESTYLE® 995MS25 (UDI 00643169002036)Recalls & reported problems

Medtronic, Inc. · VLV 995MS25 FREESTYLE MS US TEMP IND · Class 3 · Implant

All models of FREESTYLE (33)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 00643169002036), received between Apr 19, 2017 and Apr 19, 2017 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Aortic Insufficiency1
  • Aortic Valve Stenosis1

Recent adverse event reports

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

  • InjuryApr 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 3 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, IT WAS REPLACED VALVE-IN-VALVE DUE TO AORTIC INSUFFICIENCY AND STENOSIS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: Aortic Insufficiency; Aortic Valve Stenosis

    MAUDE report 6503786 ↗

Other heart-valve, non-allograft tissue devices

All heart-valve, non-allograft tissue devices →

Sources and updates

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