Food, drugs, devices › CryoLife, Inc.
Device recall: CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectan
CryoLife, Inc. (Kennesaw, GA) initiated this device recall on 10 Nov 2020; FDA lists 2 product records under event 86890, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 26 Oct 2021. Initiation: voluntary: firm initiated. CryoLife, Inc. has 12 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
CryoLife, Inc., Kennesaw, GA.
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."
Distribution
"Distributed nationwide to GA, AZ, TX, MO, and OK."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0652-2021 | 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… | 3 units | Class II | Terminated | 30 Dec 2020 |
| Z-0653-2021 | CryoPatch 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 system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the patch into the… | 2 units | Class II | Terminated | 30 Dec 2020 |
Context
Other enforcement events for CryoLife, Inc.
All 12 events for CryoLife, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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 subjected to the recall."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed nationwide to GA, AZ, TX, MO, and OK."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 26 Oct 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.