Z-0652-2021Class II

CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing...

Name: Z-0652-2021 CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing...
Creator: CryoLife, Inc.
Published: 2020-11-10
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2020-11-10 / Terminated / root cause: manufacturing process

FDA source

CryoLife, Inc. began a recall of CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a... on 2020-11-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0652-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-10
Posted: 2020-12-21
Terminated: 2021-10-26
Recalling firm: Artivion, Inc.
Product: 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 135C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.
Product code: OHA Heart Valve, More Than Minimally Manipulated Allograft
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: A Recall notification letter titled "Urgent - Voluntary Human Tissue Recall" was sent to consignees via email or hand delivered by firm representatives. On 11-Nov-2020, 4 letters were delivered to consignees. On 12-Nov-2020, 2 letters were delivered to consignees. The letter instructs the consignee to complete and return the enclosed postcard affirming that they received the notification. The affected product should be quarantined and returned to CryoLife immediately, if it has not been implanted. CryoLife Field Representatives were to provide information necessary to arrange for the return of the affected product. If the product has been implanted and the consignee has questions or requires clarification, the consignee is to contact Dr. Gregory Ray, CryloLife Medical Director at 800-438-8285.
Quantity in commerce: 3 units
Distribution: Distributed nationwide to GA, AZ, TX, MO, and OK.
Product codes and lots: Model/Catalog Number: SGPV00 Serial Numbers: 11685214, 11685554, and 11682491 UDI: 00877234000447

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0652-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0652-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-21
Z-0653-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-21

Product code OHA

K092021UnclassifiedCryovalve Sg Pulmonary Human Heart Valve (and Conduit)Cryolife, Inc. / cleared 2010-05-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)