MOSAIC ULTRARecalls & reported problems across all models
Medtronic, Inc. · 40 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,153
- Deaths reported
- 28
- Injuries reported
- 2,011
- Recalls
- 0
We found 40 models of MOSAIC ULTRA by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 2,153 adverse event reports in the FDA's MAUDE database, received between Dec 28, 2016 and Sep 29, 2026 — classified as 28 deaths, 2,011 injuries, 114 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1,381 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 MOSAIC ULTRA problems
Device problems
- Insufficient Device Problem Information1,381
- Gradient Increase337
- Device Stenosis317
- Intravalvular regurgitation274
- Patient Device Interaction Problem113
- Adverse Event Without Identified Device or Use Problem105
- Calcified79
- Perivalvular Leak49
Patient problems
- Aortic Valve Stenosis1,090
- Aortic Valve Insufficiency/ Regurgitation564
- Insufficient Information531
- No Information329
- Aortic Insufficiency144
- Aortic Regurgitation103
- Calcium Deposits/Calcification71
- Dyspnea41
MOSAIC ULTRA models
40 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MOSAIC ULTRA® 305U23heart-valve, non-allograft tissue239 reports
- MOSAIC ULTRA® 305U25heart-valve, non-allograft tissue1 death234 reports
- MOSAIC ULTRA® 305U223heart-valve, non-allograft tissue3 deaths163 reports
- MOSAIC ULTRA® 305U225heart-valve, non-allograft tissue3 deaths151 reports
- MOSAIC ULTRA® 305U221heart-valve, non-allograft tissue135 reports
- MOSAIC ULTRA® 305U27heart-valve, non-allograft tissue1 death124 reports
- MOSAIC ULTRA® 305U21heart-valve, non-allograft tissue121 reports
- MOSAIC ULTRA® 305U227heart-valve, non-allograft tissue84 reports
- MOSAIC ULTRA® 305U223heart-valve, non-allograft tissue2 deaths76 reports
- MOSAIC ULTRA® 305U225heart-valve, non-allograft tissue3 deaths73 reports
- MOSAIC ULTRA® 305U223heart-valve, non-allograft tissue62 reports
- MOSAIC ULTRA® 305U223heart-valve, non-allograft tissue6 deaths56 reports
- MOSAIC ULTRA® 305U29heart-valve, non-allograft tissue55 reports
- MOSAIC ULTRA® 305U225heart-valve, non-allograft tissue50 reports
- MOSAIC ULTRA® 305U223heart-valve, non-allograft tissue3 deaths48 reports
- MOSAIC ULTRA® 305U225heart-valve, non-allograft tissue1 death45 reports
- MOSAIC ULTRA® 305U221heart-valve, non-allograft tissue44 reports
- MOSAIC ULTRA® 305U225heart-valve, non-allograft tissue37 reports
- MOSAIC ULTRA® 305U219heart-valve, non-allograft tissue37 reports
- MOSAIC ULTRA® 305U227heart-valve, non-allograft tissue1 death35 reports
- MOSAIC ULTRA® 305U227heart-valve, non-allograft tissue30 reports
- MOSAIC ULTRA® 305U223heart-valve, non-allograft tissue24 reports
- MOSAIC ULTRA® 305U19heart-valve, non-allograft tissue24 reports
- MOSAIC ULTRA® 305U221heart-valve, non-allograft tissue20 reports
- MOSAIC ULTRA® 305U221heart-valve, non-allograft tissue19 reports
- MOSAIC ULTRA® 305U221heart-valve, non-allograft tissue1 death19 reports
- MOSAIC ULTRA® 305U225heart-valve, non-allograft tissue17 reports
- MOSAIC ULTRA® 305U221heart-valve, non-allograft tissue17 reports
- MOSAIC ULTRA® 305U223heart-valve, non-allograft tissue15 reports
- MOSAIC ULTRA® 305U229heart-valve, non-allograft tissue14 reports
- MOSAIC ULTRA® 305U219heart-valve, non-allograft tissue1 death12 reports
- MOSAIC ULTRA® 305U229heart-valve, non-allograft tissue11 reports
- MOSAIC ULTRA® 305U227heart-valve, non-allograft tissue10 reports
- MOSAIC ULTRA® 305U219heart-valve, non-allograft tissue1 death10 reports
- MOSAIC ULTRA® 305U229heart-valve, non-allograft tissue1 death10 reports
- MOSAIC ULTRA® 305U225heart-valve, non-allograft tissue9 reports
- MOSAIC ULTRA® 305U219heart-valve, non-allograft tissue9 reports
- MOSAIC ULTRA® 305U23heart-valve, non-allograft tissue8 reports
- MOSAIC ULTRA® 305U219heart-valve, non-allograft tissue5 reports
- MOSAIC ULTRA® 305U219heart-valve, non-allograft tissue1 report
Recent MOSAIC ULTRA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Patient Device Interaction Problem
Medtronic received information that 4 years and 5 months post implant of this 23mm aortic bioprosthetic valve, a permanent pacemaker was implanted. The reason for the permanent pacemaker was reported as sick sinus syndrome (SSS). No additional adverse patient effects were reported.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 50929233 ↗MalfunctionSep 25, 2026Device Stenosis
It was reported that 10 years and 1 month 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 reported as aortic stenosis. Evidence of moderate calcium was seen in the valve leaflet. No intervention or adverse patient effects were reported.
Patient problems: Aortic Valve Stenosis
MAUDE report 50895141 ↗InjurySep 25, 2026Patient Device Interaction Problem
It was reported that 4 years and 11 months post implant of this 25mm aortic bioprosthetic valve, a permanent pacemaker was implanted. The reason for the permanent pacemaker was reported as incomplete atrioventricular block (AVB). No additional adverse patient effects were reported.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 50894693 ↗InjurySep 23, 2026Patient Device Interaction Problem
Medtronic received information that 6 days post implant of this 25mm Mosaic heart valve, a permanent pacemaker was implanted. The reason for the permanent pacemaker was not reported. No additional adverse patient effects were reported.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 50866038 ↗MalfunctionSep 22, 2026Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation
Medtronic received information that 7 years and 2 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 not reported. No intervention or adverse patient effects were reported.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Insufficient Information
MAUDE report 50851589 ↗InjurySep 21, 2026Insufficient Device Problem Information
Medtronic received information that 11 years and 7 months 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 50836460 ↗MalfunctionSep 18, 2026Insufficient Device Problem Information; Device Stenosis
Medtronic received information that for an unknown duration 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: Aortic Valve Stenosis; Insufficient Information
MAUDE report 50814679 ↗InjurySep 17, 2026Device Stenosis; Intravalvular regurgitation
Medtronic received information that 10 years and 7 months post implant of this 27mm Mosaic aortic bioprosthetic valve, a transcatheter valve was implanted valve-in-valve. The reason for intervention was reported as severe aortic regurgitation (AR) and moderate aortic stenosis (AS). No additional adverse patient effects were reported.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis
MAUDE report 50804044 ↗InjurySep 14, 2026Intravalvular regurgitation
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 50762976 ↗MalfunctionSep 11, 2026Device Stenosis
Patient problems: Aortic Valve Stenosis
MAUDE report 50734202 ↗InjuryAug 31, 2026Calcified; Device Stenosis; Intravalvular regurgitation
Additional Information received reported that an intervention was planned for (b)(6)2026. Evidence of calcification was seen in the the left ventricular outflow tract (LVOT) under right coronary cusp (RCC), left coronary cusp (LCC), and non coronary cusp (NCC). No additional adverse patient effects were reported.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Calcium Deposits/Calcification; Syncope/Fainting
MAUDE report 50517390 ↗MalfunctionAug 26, 2026Calcified; Device Stenosis
Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification
MAUDE report 50451946 ↗InjuryAug 23, 2026Intravalvular regurgitation
It was reported that 7 years and 6 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 severe aortic insufficiency. It was reported that an intervention is required. No additional adverse patient effects were reported.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 50397419 ↗MalfunctionAug 17, 2026Insufficient Device Problem Information
It was reported that an unknown duration 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 not reported. No intervention or adverse patient effects were reported.
Patient problems: Insufficient Information
MAUDE report 50271459 ↗InjuryAug 4, 2026Intravalvular regurgitation
It was reported that 11 years and 2 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 moderate to severe aortic central regurgitation. It was reported that an intervention was required and subsequently on the same day, the patient successfully had a 23mm aortic transcatheter valve-in-valve replacement. No additional adverse patient effects were reported.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 50135352 ↗
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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