FREESTYLE® FR995-27 (UDI 00643169002173)Recalls & reported problems
Medtronic, Inc. · VLV FR995-27 FREESTYLE AOR NNA US TEMP I · Class 3 · Implant
All models of FREESTYLE (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169002173), received between Apr 1, 2024 and Nov 4, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Intravalvular regurgitation” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Intravalvular regurgitation2
- Insufficient Device Problem Information1
Patient problems
- Aortic Valve Insufficiency/ Regurgitation2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 4, 2025Intravalvular regurgitation; Intravalvular regurgitation
SUBSEQUENTLY, 3 WEEKS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC REGURGITATION (AR). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 23461966 ↗InjuryJul 8, 2024Intravalvular regurgitation; Intravalvular regurgitation
MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 4 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC INSUFFICIENCY (AI). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 2 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 19687460 ↗InjuryApr 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 5 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 19015208 ↗
Other heart-valve, non-allograft tissue devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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