Heart-Valve, Allograft
FDA adverse event reports and recall history for heart-valve, allograft (product code MIE), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 474
- Deaths
- 36
- Injuries
- 345
- Malfunctions
- 30
Reports per year
Source: FDA adverse event reports by year received, 2011–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2011-02-11TerminatedOther
Pulmonary Valve & Conduit SG Used in heart surgery
A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus.
- 2008-09-01TerminatedMaterial/Component Contamination
CryoValve, Aortic Valve & Conduit
Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
- 2008-09-01TerminatedMaterial/Component Contamination
CryoValve, Pulmonary Valve & Conduit
Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
- 2007-06-07TerminatedOther
CryoValve, Pulmonary Valve & Conduit
Donor tissue was released prior to information received regarding a pericardial effusion.
- 2007-06-07TerminatedOther
Aortic Valve & Conduit
Donor tissue was released prior to information received regarding a pericardial effusion.
- 2006-02-04TerminatedOther
CryoValve, Pulmonary Valve & Conduit
During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.
- 2006-02-04TerminatedOther
CryoValve, Aortic Valve &Conduit
During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.
- 2006-02-04TerminatedOther
CryoValve, Pulmonary Valve & Conduit SG
During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.
- 2006-02-04TerminatedOther
CryoValve, Pulmonary Valve & Conduit
Additional serological testing performed after distribution indicates the donor has a past Hepatitis B infection.
- 2005-11-30TerminatedOther
CryoValve, Alt Aortic Valve & Conduit
Previously released tissues no longer meet CryoLife's enhanced suitability release criteria because donors possessed a positive post processing microbiological culture of 'potentially pathogenic' organisms.
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