FREESTYLE® 995MS19Recalls & reported problems
Medtronic, Inc. · VLV 995MS19 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 00643169002395), received between Nov 20, 2023 and Nov 20, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Gradient Increase” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Gradient Increase1
- Patient Device Interaction Problem1
Patient problems
- Heart Failure/Congestive Heart Failure1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2023Gradient Increase; Patient Device Interaction Problem; Gradient Increase; Patient Device Interaction Problem
ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS WORSENING CONGESTIVE HEART FAILURE, AND A MEAN GRADIENT OF 42MMHG CAUSED BY A SEPTAL HUMP UNDERNEATH THE RIGHT CORONARY CUSPS. IT WAS ALSO REPORTED THAT A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WAS NOT PERFORMED DUE TO THE PATIENT HAVING A SMALL ANNULUS AND SMALL LEFT VENTRICULAR OUTFLOW TRACT (LVOT). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information
MAUDE report 18179124 ↗
Other heart-valve, non-allograft tissue devices
- INSPIRIS RESILIA AORTIC VALVE 11500AEdwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue2 deaths404 reports
- INSPIRIS RESILIA AORTIC VALVE 11500AEdwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue385 reports
- PERCEVAL PVS23Corcym Canada Corp · heart-valve, non-allograft tissue26 deaths337 reports
- MOSAIC® 305C23Medtronic, Inc. · heart-valve, non-allograft tissue327 reports
- MOSAIC® 305C25Medtronic, Inc. · heart-valve, non-allograft tissue2 deaths324 reports
- FREESTYLE® FR995-27Medtronic, Inc. · heart-valve, non-allograft tissue2 deaths318 reports
- FREESTYLE® FR995-29Medtronic, Inc. · heart-valve, non-allograft tissue288 reports
- FREESTYLE® FR99525Medtronic, Inc. · heart-valve, non-allograft tissue2 deaths280 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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