CryoLife, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0652-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a liquid nitrogen freezer for long-term storage at or below 135¿C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.

Product Classification:

Class II

Date Initiated: November 10, 2020

Date Posted: December 30, 2020

Recall Number: Z-0652-2021

Event ID: 86890

Reason for Recall:

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.

Status: Terminated

Product Quantity: 3 units

Code Information:

Model/Catalog Number: SGPV00 Serial Numbers: 11685214, 11685554, and 11682491 UDI: 00877234000447

Distribution Pattern:

Distributed nationwide to GA, AZ, TX, MO, and OK.

Voluntary or Mandated:

Voluntary: Firm initiated