MOSAICRecalls & reported problems across all models
Medtronic, Inc. · 59 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,632
- Deaths reported
- 77
- Injuries reported
- 2,464
- Recalls
- 2
We found 59 models of MOSAIC by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 2,632 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2016 and Sep 30, 2026 — classified as 77 deaths, 2,464 injuries, 91 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1,725 reports).
2 FDA recall records name at least one of these models by its device identifier.
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
MOSAIC recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 21, 2019Terminated
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
Z-1881-2019 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
- May 21, 2019Terminated
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
Z-1880-2019 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
Most reported MOSAIC problems
Device problems
- Insufficient Device Problem Information1,725
- Gradient Increase283
- Adverse Event Without Identified Device or Use Problem248
- Patient Device Interaction Problem233
- Device Stenosis215
- Intravalvular regurgitation201
- Calcified73
- Perivalvular Leak56
Patient problems
- Aortic Valve Stenosis788
- Insufficient Information761
- No Information468
- Aortic Valve Insufficiency/ Regurgitation429
- Aortic Insufficiency157
- Non specific EKG/ECG Changes148
- Aortic Regurgitation108
- Endocarditis103
MOSAIC models
59 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MOSAIC® 305C23heart-valve, non-allograft tissue327 reports
- MOSAIC® 305C25heart-valve, non-allograft tissue2 deaths324 reports
- MOSAIC® 310C29heart-valve, non-allograft tissue1 recall13 deaths133 reports
- MOSAIC® 310C31heart-valve, non-allograft tissue1 recall11 deaths126 reports
- MOSAIC® 305C27heart-valve, non-allograft tissue170 reports
- MOSAIC® 305C21heart-valve, non-allograft tissue161 reports
- MOSAIC® 305C223heart-valve, non-allograft tissue1 death80 reports
- MOSAIC® 310C29heart-valve, non-allograft tissue2 deaths75 reports
- MOSAIC® 310C27heart-valve, non-allograft tissue9 deaths71 reports
- MOSAIC® 305C225heart-valve, non-allograft tissue1 death67 reports
- MOSAIC® 310C31heart-valve, non-allograft tissue3 deaths63 reports
- MOSAIC® 310C33heart-valve, non-allograft tissue4 deaths60 reports
- MOSAIC® 310C27heart-valve, non-allograft tissue7 deaths57 reports
- MOSAIC® 305C227heart-valve, non-allograft tissue1 death57 reports
- MOSAIC® 305C29heart-valve, non-allograft tissue57 reports
- MOSAIC® 310C25heart-valve, non-allograft tissue14 deaths56 reports
- MOSAIC® 310C27heart-valve, non-allograft tissue52 reports
- MOSAIC® 305C221heart-valve, non-allograft tissue49 reports
- MOSAIC® 310C31heart-valve, non-allograft tissue1 death49 reports
- MOSAIC® 310C29heart-valve, non-allograft tissue46 reports
- MOSAIC® 305C223heart-valve, non-allograft tissue39 reports
- MOSAIC® 310C33heart-valve, non-allograft tissue1 death38 reports
- MOSAIC® 310C25heart-valve, non-allograft tissue2 deaths35 reports
- MOSAIC® 310C25heart-valve, non-allograft tissue32 reports
- MOSAIC® 305C225heart-valve, non-allograft tissue26 reports
- MOSAIC® 305C225heart-valve, non-allograft tissue24 reports
- MOSAIC® 305C223heart-valve, non-allograft tissue24 reports
- MOSAIC® 305C225heart-valve, non-allograft tissue1 death23 reports
- MOSAIC® 310C33heart-valve, non-allograft tissue23 reports
- MOSAIC® 305C227heart-valve, non-allograft tissue19 reports
- MOSAIC® 305C221heart-valve, non-allograft tissue18 reports
- MOSAIC® 310C29heart-valve, non-allograft tissue17 reports
- MOSAIC® 310C31heart-valve, non-allograft tissue16 reports
- MOSAIC® 305C227heart-valve, non-allograft tissue1 death16 reports
- MOSAIC® 305C19heart-valve, non-allograft tissue15 reports
- MOSAIC® 310C27heart-valve, non-allograft tissue14 reports
- MOSAIC® 305C223heart-valve, non-allograft tissue14 reports
- MOSAIC® 310C25heart-valve, non-allograft tissue11 reports
- MOSAIC® 305C221heart-valve, non-allograft tissue11 reports
- MOSAIC® 305C229heart-valve, non-allograft tissue11 reports
- MOSAIC® 305C223heart-valve, non-allograft tissue11 reports
- MOSAIC® 305C225heart-valve, non-allograft tissue10 reports
- MOSAIC® 305C225heart-valve, non-allograft tissue10 reports
- MOSAIC® 305C225heart-valve, non-allograft tissue10 reports
- MOSAIC® 305C223heart-valve, non-allograft tissue9 reports
- MOSAIC® 305C223heart-valve, non-allograft tissue9 reports
- MOSAIC® 305C221heart-valve, non-allograft tissue3 deaths9 reports
- MOSAIC® 305C221heart-valve, non-allograft tissue7 reports
- MOSAIC® 305C227heart-valve, non-allograft tissue6 reports
- MOSAIC® 305C219heart-valve, non-allograft tissue6 reports
- MOSAIC® 305C229heart-valve, non-allograft tissue6 reports
- MOSAIC® 310C33heart-valve, non-allograft tissue5 reports
- MOSAIC® 305C23heart-valve, non-allograft tissue5 reports
- MOSAIC® 305C221heart-valve, non-allograft tissue4 reports
- MOSAIC® 305C229heart-valve, non-allograft tissue4 reports
- MOSAIC® 305C219heart-valve, non-allograft tissue4 reports
- MOSAIC® 305C219heart-valve, non-allograft tissue4 reports
- MOSAIC® 305C25heart-valve, non-allograft tissue4 reports
- MOSAIC® 305C219heart-valve, non-allograft tissue3 reports
Recent MOSAIC adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Patient Device Interaction Problem
It was reported that 11 years and 7 months post implant of this 29mm mitral bioprosthetic valve, the patient was admitted to the hospital for heart failure. It was reported during the admission the patient was told that one of her mitral valve leaflets was "flapping". It was reported that the patient had follow-up echocardiogram which demonstrated a drop in ejection fraction (EF) to 50-54% and an extended left ventricle (LV). No intervention or adverse patient effects were reported.
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 50943694 ↗InjurySep 25, 2026Intravalvular regurgitation
It was reported that 9 years and 2 months post implant of this 25mm mitral bioprosthetic valve implanted in the tricuspid position, the patient received a replacement. The reason for intervention was reported as regurgitation. No additional adverse patient effects were reported.
Patient problems: Tricuspid Valve Insufficiency/ Regurgitation
MAUDE report 50896603 ↗InjurySep 25, 2026Insufficient Device Problem Information
Medtronic received information that 7 years and 6 months post implant of this 29mm mitral bioprosthetic valve, it was explanted and replaced with a new 29mm mitral bioprosthetic valve of a different model. The reason for the replacement was not reported. No additional adverse patient effects were reported.
Patient problems: Insufficient Information
MAUDE report 50896357 ↗MalfunctionSep 25, 2026Insufficient Device Problem Information
Medtronic received information that 12 years and 2 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 50895015 ↗InjurySep 25, 2026Patient Device Interaction Problem
Medtronic received information that 7 months post implant of this 29mm mitral bioprosthetic valve, a defibrillator was implanted. The reason for the defibrillator was reported as low ejection fraction (EF). No additional adverse patient effects were reported.
Patient problems: Non specific EKG/ECG Changes
MAUDE report 50894809 ↗DeathSep 23, 2026Insufficient Device Problem Information
It was reported that during the implant of this 27mm mitral bioprosthetic valve, it was explanted and replaced with a new 27mm mitra l bioprosthetic valve of the same model or vice versa. The reason for the replacement was not reported. It was further reported that on the same day the patient was reported deceased. It was noted that the mitral device which remained implanted in the patient was unconfirmed. The cause of death was not received. Therefore, relatedness of the death to the valves could not be excluded. It is unknown whether an autopsy was performed.
Patient problems: Insufficient Information
MAUDE report 50866012 ↗DeathSep 23, 2026Insufficient Device Problem Information
It was reported that during the implant of this 27mm mitral bioprosthetic valve, it was explanted and replaced with a new 27mm mitra l bioprosthetic valve of the same model or vice versa. The reason for the replacement was not reported. It was further reported that on the same day the patient was reported deceased. It was noted that the mitral device which remained implanted in the patient was unconfirmed. The cause of death was not received. Therefore, relatedness of the death to the valves could not be excluded. It is unknown whether an autopsy was performed.
Patient problems: Insufficient Information
MAUDE report 50866010 ↗InjurySep 22, 2026Patient Device Interaction Problem
It was reported that 7 years and 6 months post implant of this 21mm aortic bioprosthetic valve, a permanent pacemaker was implanted. The reason for the permanent pacemaker was reported as complete heart block (CHB). No additional adverse patient effects were reported.
Patient problems: Heart Block
MAUDE report 50852836 ↗InjurySep 22, 2026Device Stenosis
It was reported that approximately 12 years and 1 month post implant of this 29mm mitral bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement or a surgical valve replacement. The reason for evaluation was reported as mitral stenosis. It was reported that an intervention was required. No additional adverse patient effects were reported.
Patient problems: Mitral Valve Stenosis
MAUDE report 50852532 ↗InjurySep 22, 2026Patient Device Interaction Problem
Medtronic received information that 2 years and 2 months post implant of this 27mm mitral bioprosthetic heart 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 50851500 ↗DeathSep 21, 2026Insufficient Device Problem Information
Medtronic received information that an unknown duration post implant of this 31mm Mosaic heart valve, the patient died. The cause of death was not received. Therefore, relatedness of the death to the Mosaic heart valve could not be excluded. It is unknown whether an autopsy was performed.
Patient problems: Insufficient Information
MAUDE report 50840634 ↗InjurySep 18, 2026Intravalvular regurgitation
It was reported that approximately 12 years 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 insufficiency (AI). It was reported that an intervention was required. No additional adverse patient effects were reported.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 50817133 ↗InjurySep 17, 2026Insufficient Device Problem Information
It was reported that during the implant of this 29mm mitral bioprosthetic valve, it was explanted and replaced with an unknown devic e. The reason for the replacement was not reported. No additional adverse patient effects were reported.
Patient problems: Insufficient Information
MAUDE report 50798767 ↗InjurySep 16, 2026Patient Device Interaction Problem
Medtronic received information that 15 years post implant of this 23mm aortic bioprosthetic valve, it was explanted and replaced with an unknown product. The reason for the replacement was reported as infection. No additional adverse patient effects were reported.
Patient problems: Unspecified Infection
MAUDE report 50788657 ↗InjurySep 14, 2026Insufficient Device Problem Information
Medtronic received information from a patient that approximately 10 years post-implant of this 29mm Mosaic mitral bioprosthetic valve, it was explanted and replaced with an unknown valve. It was reported by the patient that the valve was no longer active and had expired. The patient also stated that they no longer had the device. The reason for the replacement was not reported. No additional adverse patient effects were reported.
Patient problems: Insufficient Information
MAUDE report 50750919 ↗
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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