FREESTYLERecalls & reported problems across all models
Medtronic, Inc. · 33 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,754
- Deaths reported
- 44
- Injuries reported
- 1,654
- Recalls
- 0
We found 33 models of FREESTYLE by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,754 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2016 and Sep 30, 2026 — classified as 44 deaths, 1,654 injuries, 56 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1,204 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported FREESTYLE problems
Device problems
- Insufficient Device Problem Information1,204
- Intravalvular regurgitation264
- Patient Device Interaction Problem128
- Adverse Event Without Identified Device or Use Problem116
- Device Stenosis99
- Calcified80
- Gradient Increase78
- Material Split, Cut or Torn63
Patient problems
- Aortic Valve Insufficiency/ Regurgitation532
- Insufficient Information442
- Aortic Valve Stenosis355
- No Information295
- Aortic Insufficiency232
- Aortic Regurgitation153
- Calcium Deposits/Calcification82
- Cusp Tear60
FREESTYLE models
33 models, most reported first. Each model has its own page with its reports, recalls and device details.
- FREESTYLE® FR995-27heart-valve, non-allograft tissue2 deaths318 reports
- FREESTYLE® FR995-29heart-valve, non-allograft tissue288 reports
- FREESTYLE® FR99525heart-valve, non-allograft tissue2 deaths280 reports
- FREESTYLE® FR995-23heart-valve, non-allograft tissue192 reports
- FREESTYLE® FR995-27heart-valve, non-allograft tissue10 deaths129 reports
- FREESTYLE® FR995-29heart-valve, non-allograft tissue6 deaths118 reports
- FREESTYLE® FR995-25heart-valve, non-allograft tissue9 deaths100 reports
- FREESTYLE® FR995-21heart-valve, non-allograft tissue76 reports
- FREESTYLE® FR995-23heart-valve, non-allograft tissue8 deaths72 reports
- FREESTYLE® FR995-21heart-valve, non-allograft tissue2 deaths29 reports
- FREESTYLE® FR995-19heart-valve, non-allograft tissue19 reports
- FREESTYLE® 995MS29heart-valve, non-allograft tissue15 reports
- FREESTYLE® 995MS29heart-valve, non-allograft tissue1 death15 reports
- FREESTYLE® FR995-19heart-valve, non-allograft tissue1 death12 reports
- FREESTYLE® 995CS25heart-valve, non-allograft tissue12 reports
- FREESTYLE® 995MS27heart-valve, non-allograft tissue10 reports
- FREESTYLE® 995CS27heart-valve, non-allograft tissue8 reports
- FREESTYLE® 995MS23heart-valve, non-allograft tissue8 reports
- FREESTYLE® 995MS25heart-valve, non-allograft tissue7 reports
- FREESTYLE® FR995-29heart-valve, non-allograft tissue6 reports
- FREESTYLE® FR995-29heart-valve, non-allograft tissue6 reports
- FREESTYLE® FR995-27heart-valve, non-allograft tissue5 reports
- FREESTYLE® 995CS21heart-valve, non-allograft tissue5 reports
- FREESTYLE® 995CS23heart-valve, non-allograft tissue5 reports
- FREESTYLE® 995CS23heart-valve, non-allograft tissue4 reports
- FREESTYLE® FR995-27heart-valve, non-allograft tissue3 reports
- FREESTYLE® 995CS27heart-valve, non-allograft tissue2 deaths3 reports
- FREESTYLE® 995CS21heart-valve, non-allograft tissue2 reports
- FREESTYLE® 995CS25heart-valve, non-allograft tissue2 reports
- FREESTYLE® 995CS19heart-valve, non-allograft tissue2 reports
- FREESTYLE® 995MS25heart-valve, non-allograft tissue1 report
- FREESTYLE® 995MS19heart-valve, non-allograft tissue1 report
- FREESTYLE® 995MS21heart-valve, non-allograft tissue1 death1 report
Recent FREESTYLE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Calcified; Device Stenosis
It was reported that 11 years and 1 month post implant of this 19mm aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement. The reason for evaluation was reported as aortic stenosis. Evidence of calcification was seen in the sino-tubular junction (STJ). No intervention or adverse patient effects were reported.
Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification
MAUDE report 50943946 ↗InjurySep 30, 2026Patient Device Interaction Problem
Medtronic received information that 6 years and 8 months post implant of this 27mm aortic bioprosthetic valve, a Bi-Ventricular Defibrillator was implanted. The reason for the Bi-Ventricular Defibrillator was reported as low ejection fraction (EF). No additional adverse patient effects were reported.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 50942994 ↗InjurySep 29, 2026Insufficient Device Problem Information
Medtronic received information that 3 years 3 month post implant of this 23mm aortic bioprosthetic valve, the patient was being evaluated for a transcatheter valve-in-valve replacement. The reason for evaluation was not reported. It was reported that an intervention was required. No additional adverse patient effects were reported.
Patient problems: Insufficient Information
MAUDE report 50929371 ↗InjurySep 29, 2026Insufficient Device Problem Information
Medtronic received information that 8 days post implant of this 27mm aortic bioprosthetic valve, it was explanted and replaced with a new 27mm aortic bioprosthetic 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 50928922 ↗MalfunctionSep 25, 2026Insufficient Device Problem Information
Medtronic received information that 14 years and 9 months post implant of this 25mm aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement. The reason for evaluation was not reported. No intervention or adverse patient effects were reported.
Patient problems: Insufficient Information
MAUDE report 50895043 ↗MalfunctionSep 25, 2026Device Stenosis
Medtronic received information that 7 years and 7 months post implant of this 23mm aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement. The reason for evaluation was reported as aortic valve stenosis (AS). No intervention or additional adverse patient effects were reported.
Patient problems: Aortic Valve Stenosis
MAUDE report 50894945 ↗InjurySep 18, 2026Insufficient Device Problem Information
Medtronic received information that approximately 11 years post implant of this 29mm aortic bioprosthetic valve, it was explanted and replaced with an unknown device. The reason for the replacement was not reported. No additional adverse patient effects were reported.
Patient problems: Insufficient Information
MAUDE report 50815200 ↗InjurySep 16, 2026Insufficient Device Problem Information
Medtronic received information that 13 years post implant of this 25mm aortic bioprosthetic valve, a 26mm aortic transcatheter valve was implanted valve-in-valve. The reason for intervention was not reported. No additional adverse patient effects were reported.
Patient problems: Insufficient Information
MAUDE report 50784941 ↗MalfunctionSep 15, 2026Insufficient Device Problem Information
It was reported that 13 years and 4 months post implant of this 29mm aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement. The reason for evaluation was not reported. Evidence of calcification was seen in the Sino-tubular junction (STJ) and in ascending aorta. No intervention or adverse patient effects were reported.
Patient problems: Calcium Deposits/Calcification
MAUDE report 50768094 ↗InjuryAug 23, 2026Gradient Increase; Device Stenosis
It was reported that 4 years and 6 months post implant of this 19mm aortic bioprosthetic valve implanted in the pulmonary position, in a 4 year old pediatric patient, a 16mm pulmonary transcatheter valve was implanted valve-in-valve. The reason for intervention was reported as severe conduit stenosis with peak gradient of 50-55mmHg. It was noted that the reason for replacement was not the result of somatic outgrowth of the original conduit. No additional adverse patient effects were reported.
Patient problems: Pulmonary Valve Stenosis
MAUDE report 50397181 ↗InjuryAug 4, 2026Patient Device Interaction Problem; Intravalvular regurgitation
Additional information was received that the patient successfully had a 34mm aortic transcatheter valve-in-valve replacement. No additional adverse patient effects were reported.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Chest Pain; Dizziness; Dyspnea
MAUDE report 50135395 ↗InjuryJul 30, 2026Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation
Additional Information received reported that on (b)(6), 2026, during intubation the patient coded and was not able to be resuscitated. The cause of death was not received. It was reported the death was not related to the freestyle valve. It is unknown whether an autopsy was performed.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Calcium Deposits/Calcification; Cardiac Arrest
MAUDE report 50084682 ↗InjuryJul 28, 2026Patient Device Interaction Problem
Medtronic received information that 3 years and 4 months post implant of this 29mm Freestyle heart valve, a Bi-Ventricular Defibrillator was implanted. The reason for the Bi-Ventricular Defibrillator was reported as low ejection fraction (EF) and complete heart block (CHB). No additional adverse patient effects were reported.
Patient problems: Heart Block
MAUDE report 50059145 ↗DeathJul 28, 2026Insufficient Device Problem Information
Medtronic received information that 5 days post implant of this 23mm aortic aortic bioprosthetic valve, the patient died. The cause of death was not received. Therefore, relatedness of the death to the valve can not be excluded. It is unknown whether an autopsy was performed.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50051475 ↗InjuryJun 19, 2026Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 29 AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 25564155 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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