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U.S. Department of Health and Human Services

Class 2 Device Recall OnX Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft

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  Class 2 Device Recall OnX Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft see related information
Date Initiated by Firm February 12, 2014
Create Date September 06, 2017
Recall Status1 Terminated 3 on November 05, 2019
Recall Number Z-3108-2017
Recall Event ID 77728
PMA Number P000037 
Product Classification Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
Product 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.
Code Information Model No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902
Recalling Firm/
Manufacturer		 CryoLife, Inc.
1655 Roberts Blvd NW
Kennesaw GA 30144-3632
For Additional Information Contact Tamara Cardona
770-419-3355
Manufacturer Reason
for Recall		 Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
FDA Determined
Cause 2		 Other
Action On February 12, 2014, it was discovered that five devices were processed under the wrong RGA number This is a retrospective reporting. Three units were collected and returned to the firm, while two were implanted. For further questions, please call ( 770) 419-3355.
Quantity in Commerce 5 units
Distribution US Distribution to the state of : Illinois
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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