Cryolife, Inc.
FDA adverse event reports naming Cryolife, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: CRYOLIFE, INC..
- Total reports
- 1,416
- Deaths
- 166
- Injuries
- 1,018
- Malfunctions
- 75
Reports per year
Source: FDA adverse event reports by year received, 2009–2023. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Glue, Surgical, ArteriesMUQ403
- Heart-Valve, AllograftMIE388
- Prosthesis, Vascular Graft, Of 6mm And Greater DiameterDSY289
- Product code MFIMFI105
- Heart Valve, More Than Minimally Manipulated AllograftOHA58
- Heart-Valve, Non-Allograft TissueLWR43
- System, Laser, Transmyocardial RevascularizationMNO41
- Patch, Pledget And Intracardiac, Petp, Ptfe, PolypropyleneDXZ34
- Intracardiac Patch Or Pledget, Biologically DerivedPSQ14
- Heart-Valve, MechanicalLWQ13
Recent recalls
- 2014-05-30TerminatedProcess control
BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of of large vessels (such as aorta, femoral, and carotid arteries).
Serum albumin component monomer failed to meet internally established end of shelf-life specification.
- 2014-01-23TerminatedOther
Pulmonary Hemi-Artery SG Used in heart surgery
Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.
- 2011-03-04TerminatedOther
Pulmonary Valve & Conduit SG Used in heart surgery
Staphylococcus aureus (not methicillin resistant) identified in companion tissue.
- 2011-03-04TerminatedOther
Pulmonary Hemi-Artery SG Used in heart surgery
Staphylococcus aureus (not methicillin resistant) identified in companion tissue.
- 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.
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