Devices

Device Recall bileaflet mechanical heart valve

Model / Serial
Serial #'s: 4622210, 4587605, 4741470, 4750714, 4622025, 4737722, 4737726, 4632012, 4237725, 4616112, 4520208, 4520709, 4632013, 4771217, 4771005, 4781414, 4782107, 4782132, 4765118, 4750707, 4508717, 4525417, 4520719, 4771302, 4771302, 4771210, 4751315, 4741406, 4616313, 4781416, 4771305, 4737922, 4520711, 4508804, 4508807, 4712108, 4765119, 4765106, 4587712, 4525415, 4622315, 4622126, 4771205, 4001123, 4771202, 4780914, 4741412, 4717904, 4671765, 458719, 4622225, and 4731908
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide Distribution - US Nationwide in the states of AL, CA, FL, IA, IN, LA, MA, MN, MO, MS, NC, OR, PA, and TN. and the countries of Finland, United Kingdom and Israel
Product Description
On-X Prosthetic Heart Valve || Product Usage: || Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions
Manufacturer
CryoLife, Inc.
1 Event
- Recall of Device Recall bileaflet mechanical heart valve

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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