CryoValve SG Pulmonary Human Heart Valve. The valve is… recallZ-0652-2021 · CryoLife, Inc. · initiated Nov 10, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CryoLife, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Material/Component Contamination
What the company is doing
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.
Recall details
- Recall number
- Z-0652-2021
- Status
- Terminated
- Initiated by the company
- Nov 10, 2020
- Recalling firm
- CryoLife, Inc.
- Quantity
- 3 units
- Product code
- OHA
- FDA submissions
- K092021
- Distribution
- Distributed nationwide to GA, AZ, TX, MO, and OK.
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 135C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.
Code information (models, lots, serial numbers)
Model/Catalog Number: SGPV00 Serial Numbers: 11685214, 11685554, and 11682491 UDI: 00877234000447
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CryoValve® SG Pulmonary Human Heart Valve SGPV00Artivion, Inc. · Heart Valve, More Than Minimally Manipulated Allograft3 recalls1 death8 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 86890).
- Z-0653-2021 · TerminatedCryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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