FREESTYLE® 995CS23 (UDI 00643169002265)Recalls & reported problems
Medtronic, Inc. · VLV 995CS23 FREESTYLE CS 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169002265), received between Nov 4, 2021 and Feb 6, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Intravalvular regurgitation2
- Inadequacy of Device Shape and/or Size1
Patient problems
- Aortic Valve Insufficiency/ Regurgitation2
- Insufficient Information2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2025Intravalvular regurgitation; Intravalvular regurgitation
IT WAS REPORTED THAT POST IMPLANT OF THIS FREESTYLE AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS SEVERE AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 21321662 ↗InjuryNov 20, 2024Intravalvular regurgitation; Intravalvular regurgitation
MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH INDICATED THAT THE SEVERITY OF AORTIC INSUFFICIENCY (AI) WAS SEVERE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 20734380 ↗InjuryDec 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 6 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM AORTIC BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 12908006 ↗InjuryNov 4, 2021Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM AORTIC BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 12754078 ↗
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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