CryoLife, Inc.
Medical device manufacturer in Kennesaw, GA.
12510(k) clearances
2PMA approvals
21recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K183635 | PhotoFix Decellularized Bovine PericardiumPSQ · Special | 02/14/2019SE |
| K172085 | PhotoFix Decellularized Bovine PericardiumPSQ · Traditional | 12/04/2017SE |
| K162506 | PhotoFix Decellularized Bovine PericardiumDXZ · Traditional | 03/09/2017SE |
| K132105 | Perclot TopicalQSY · Traditional | 04/03/2014SE |
| K110581 | Propatch Soft Tissue Repair MatrixFTM · Traditional | 01/10/2012SE |
| K101587 | Propatch Soft Tissue Repair MatrixFTM · Traditional | 09/16/2010SE |
| K101866 | Cryopatch SG Pulmonary Human Cardiac PatchDXZ · Special | 07/23/2010SE |
| K092021 | Cryovalve SG Pulmonary Human Heart Valve (and Conduit)OHA · Traditional | 05/25/2010SE |
| K091626 | Cryopatch SG Pulmonary Hemi-Artery; Trunk; BranchDXZ · Traditional | 08/07/2009SE |
| K083106 | Cryovalve SG Pulmonary Valve and ConduitOHA · Traditional | 02/06/2009SE |
| K033484 | Human Heart Valve, Cryovalve SGOHA · Traditional | 02/07/2008SE |
| K061892 | Propatch Soft Tissue Repair MatrixFTM · Abbreviated | 11/22/2006SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0384-2022 Class II | BioGlue Surgical Adhesive, Model BG3510-5-GProduct is not approved for use in the EU and should not have been distributed in the EU. | 10/07/2021Terminated |
| Z-0653-2021 Class II | CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue…On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for… | 11/10/2020Terminated |
| Z-0652-2021 Class II | CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture…On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for… | 11/10/2020Terminated |
| Z-1073-2019 Class II | On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic…On-X Valve was mislabeled with the incorrect serial number. | 01/17/2019Terminated |
| Z-0121-2019 Class II | CryoPatch SG Pulmonary Hemi-Artery, 1 graftThe conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling.… | 09/06/2018Terminated |
| Z-2556-2018 Class II | BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for…The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly… | 06/04/2018Terminated |
| Z-2272-2018 Class II | Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports… | 05/14/2018Terminated |
| Z-2271-2018 Class II | Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOODevices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports… | 05/14/2018Terminated |
| Z-2623-2017 Class II | BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-JThe courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002. | 05/19/2017Terminated |
| Z-1219-2019 Class II | CryoPatch SG Pulmonary Hemi-Artery PatchThe device is recalled due to donor ineligibility of released human tissue. The firm received information… | 11/21/2016Terminated |
| Z-2715-2017 Class II | On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased…Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of… | 06/12/2015Terminated |
| Z-1674-2014 Class II | BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is…Serum albumin component monomer failed to meet internally established end of shelf-life specification. | 04/25/2014Terminated |
| Z-3108-2017 Class II | On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the…Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients. | 02/12/2014Terminated |
| Z-0809-2014 Class II | Pulmonary Hemi-Artery SG Used in heart surgerySerological testing for the donor was performed with a blood sample that may have been hemodiluted due to… | 11/22/2013Terminated |
| Z-1561-2011 | Pulmonary Hemi-Artery SG Used in heart surgeryStaphylococcus aureus (not methicillin resistant) identified in companion tissue. | 02/17/2011Terminated |
| Z-1560-2011 | Pulmonary Valve & Conduit SG Used in heart surgeryStaphylococcus aureus (not methicillin resistant) identified in companion tissue. | 02/17/2011Terminated |
| Z-1219-2011 | Pulmonary Valve & Conduit SG Used in heart surgeryA pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for… | 01/07/2011Terminated |
| Z-1524-2008 | CryoValve, Pulmonary Valve & ConduitTissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed. | 03/26/2008Terminated |
| Z-1523-2008 | CryoValve, Aortic Valve & ConduitTissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed. | 03/26/2008Terminated |
| Z-0842-2007 | Aortic Valve & ConduitDonor tissue was released prior to information received regarding a pericardial effusion. | 04/17/2007Terminated |
| Z-0841-2007 | CryoValve, Pulmonary Valve & ConduitDonor tissue was released prior to information received regarding a pericardial effusion. | 04/17/2007Terminated |