Devices

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

Model / Serial
Model No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
US Distribution to the state of : Illinois
Product Description
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.
Manufacturer
CryoLife, Inc.
1 Event
- Recall of Device Recall OnX Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft

Manufacturer

CryoLife, Inc.

Manufacturer Address
CryoLife, Inc., 1655 Roberts Blvd NW, Kennesaw GA 30144-3632
Manufacturer Parent Company (2017)
Cryolife Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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