Food, drugs, devices › CryoLife, Inc.
Device recall: On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged
CryoLife, Inc. (Kennesaw, GA) initiated this device recall on 12 Feb 2014; FDA lists 1 product record under event 77728, 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 5 Nov 2019. 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
"Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients."
Distribution
"US Distribution to the state of : Illinois"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3108-2017 | On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease. | 5 units | Class II | Terminated | 13 Sep 2017 |
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: "Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients."
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: "US Distribution to the state of : Illinois"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Nov 2019. "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.