Z-3108-2017Class II

On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of...

Name: Z-3108-2017 On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of...
Creator: CryoLife, Inc.
Published: 2014-02-12
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2014-02-12 / Terminated

FDA source

CryoLife, Inc. began a recall of On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or... on 2014-02-12. FDA classified it as Class II and gives the reason as "Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3108-2017
Classification: Class II
Status: Terminated
Initiated: 2014-02-12
Posted: 2017-09-06
Terminated: 2019-11-05
Recalling firm: Artivion, Inc.
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.
Product code: NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Reason for recall: Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
FDA root cause: 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
Product codes and lots: Model No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3108-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3108-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-13	2017-09-06

Product code NPT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)