Cryolife, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 14
- FDA recalls
- 97
At a glance
Market reach
- United States
- FDA recalls
What Cryolife, Inc. makes
The company manufactures cryopreserved human tissue grafts, including pulmonary heart valves and conduits (e.g., CRYOVALVE SG), vascular patches for arteries and branches (e.g., CRYOPATCH SG), and soft tissue repair matrices (e.g., PROPATCH). It also produces topical hemostatic agents (e.g., PERCLOT), surgical adhesives (e.g., BIOGLUE), and a holmium laser system (ECLIPSE TMR) for tissue ablation.
These products are regulated under FDA pathways, with Class II and Class III devices subject to 510(k) and PMA authorisations, respectively. The company’s devices are listed in the FDA’s 510(k) and PMA registries, and the manufacturer is based in the United States.
Catalogue
Search and filter all 14 devicesFDA recalls
FDA recall records list 97 recalls initiated by Cryolife, Inc., the earliest on 2003-01-23 and the most recent on 2021-10-07. By recorded status: 97 terminated. The reasons filed fall into these groups: sterility or contamination and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 4
- 2019 1
- 2020 2
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 7 Oct 2021 Z-0384-2022 Class II Terminated Product is not approved for use in the EU and should not have been distributed in the EU.
2020
- 10 Nov 2020 Z-0652-2021 Class II Terminated On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.
- 10 Nov 2020 Z-0653-2021 Class II Terminated On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.
2019
- 17 Jan 2019 Z-1073-2019 Class II Terminated On-X Valve was mislabeled with the incorrect serial number.
2018
- 6 Sep 2018 Z-0121-2019 Class II Terminated The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.
- 4 Jun 2018 Z-2556-2018 Class II Terminated The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes.
- 14 May 2018 Z-2271-2018 Class II Terminated Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
- 14 May 2018 Z-2272-2018 Class II Terminated Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
2017
- 19 May 2017 Z-2623-2017 Class II Terminated The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
2016
- 21 Nov 2016 Z-1219-2019 Class II Terminated The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.
Show the 25 most recent of 97 recalls
2015
- 12 Jun 2015 Z-2715-2017 Class II Terminated Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.
Full distribution text
- 12 Jun 2015 Z-2715-2017 Class II Terminated Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.
2014
- 25 Apr 2014 Z-1674-2014 Class II Terminated Serum albumin component monomer failed to meet internally established end of shelf-life specification.
Full distribution text
- 12 Feb 2014 Z-3108-2017 Class II Terminated Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
- 25 Apr 2014 Z-1674-2014 Class II Terminated Serum albumin component monomer failed to meet internally established end of shelf-life specification.
2013
- 22 Nov 2013 Z-0809-2014 Class II Terminated 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
- 17 Feb 2011 Z-1560-2011 Unclassified (pre-2012) Terminated Staphylococcus aureus (not methicillin resistant) identified in companion tissue.
- 17 Feb 2011 Z-1561-2011 Unclassified (pre-2012) Terminated Staphylococcus aureus (not methicillin resistant) identified in companion tissue.
- 7 Jan 2011 Z-1219-2011 Unclassified (pre-2012) Terminated A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus.
2008
- 26 Mar 2008 Z-1523-2008 Unclassified (pre-2012) Terminated Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
- 26 Mar 2008 Z-1524-2008 Unclassified (pre-2012) Terminated Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
2007
- 17 Apr 2007 Z-0841-2007 Unclassified (pre-2012) Terminated Donor tissue was released prior to information received regarding a pericardial effusion.
- 17 Apr 2007 Z-0842-2007 Unclassified (pre-2012) Terminated Donor tissue was released prior to information received regarding a pericardial effusion.
2006
- 27 Jan 2006 Z-0480-06 Unclassified (pre-2012) Terminated Additional serological testing performed after distribution indicates the donor has a past Hepatitis B infection.
2005
- 17 May 2005 Z-0859-05 Unclassified (pre-2012) Terminated Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptance criteria for warm ischemic time.
- 17 May 2005 Z-0860-05 Unclassified (pre-2012) Terminated Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptance criteria for warm ischemic time.
- 12 Jan 2005 Z-0669-05 Unclassified (pre-2012) Terminated During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas.
Frequently asked questions
How many devices does Cryolife, Inc. have in the registry?
The registry currently lists 14 devices for Cryolife, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cryolife, Inc.'s devices?
Among its 14 most recently registered devices, Cryolife, Inc. has devices listed in FDA 510(k) (12 devices) and FDA PMA (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cryolife, Inc.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Cryolife, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Cryolife, Inc.?
FDA recall records list 97 recalls initiated by Cryolife, Inc., the most recent initiated on 2021-10-07. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Cryolife, Inc. in the registry?
The most recently registered devices listed for Cryolife, Inc. include PhotoFix Decellularized Bovine Pericardium, CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT), CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH and PERCLOT TOPICAL.