CryoLife Recalls
14 recalls on record · January 29, 2014 to December 22, 2021 · Medical Devices
Recalls by year
14
17
18
19
20
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 22, 2021Medical DevicesFDA
CryoLife, Inc. recalls BioGlue Surgical Adhesive, Model BG3510-5-G
Hazard: Product is not approved for use in the EU and should not have been distributed in the EU.
December 30, 2020Medical DevicesFDA
CryoLife, Inc. recalls CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotec
Hazard: 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.
December 30, 2020Medical DevicesFDA
CryoLife, Inc. recalls CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotecta
Hazard: 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.
May 1, 2019Medical DevicesFDA
CryoLife, Inc. recalls CryoPatch SG Pulmonary Hemi-Artery Patch
Hazard: 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.
April 3, 2019Medical DevicesFDA
CryoLife, Inc. recalls On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for th
Hazard: On-X Valve was mislabeled with the incorrect serial number.
October 24, 2018Medical DevicesFDA
CryoLife, Inc. recalls CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Hazard: 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.
August 1, 2018Medical DevicesFDA
CryoLife, Inc. recalls BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard
Hazard: 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.
June 27, 2018Medical DevicesFDA
CryoLife, Inc. recalls Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
Hazard: Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
June 27, 2018Medical DevicesFDA
CryoLife, Inc. recalls Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Hazard: Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
September 13, 2017Medical DevicesFDA
CryoLife, Inc. recalls On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, dama
Hazard: Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
July 19, 2017Medical DevicesFDA
CryoLife, Inc. recalls On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning nat
Hazard: Incorrect product label. The type of Sewing Ring was mislabeled as being a Standard Sewing Ring instead of an Anatomic Sewing Ring.
July 5, 2017Medical DevicesFDA
CryoLife, Inc. recalls BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
Hazard: The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
June 11, 2014Medical DevicesFDA
CryoLife, Inc. recalls BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to
Hazard: Serum albumin component monomer failed to meet internally established end of shelf-life specification.
January 29, 2014Medical DevicesFDA
CryoLife, Inc. recalls Pulmonary Hemi-Artery SG Used in heart surgery
Hazard: 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.