Devices

Device Recall CryoValve

Model / Serial
Aortic Valve & Conduit, Donor #29976, Serial #6212891, Model #AV00 and Pulmonary Valve & Conduit Donor #51562, Serial #7093095, Model #PV00
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Heart allografts were distributed to two hospitals in OH and Quebec, Canada.
Product Description
CryoValve Allograft, Heart valve.
Manufacturer
Cryolife Inc
1 Event
- Recall of Device Recall CryoValve

Manufacturer

Cryolife Inc

Manufacturer Address
Cryolife Inc, 1655 Roberts Blvd Nw, Kennesaw GA 30144
Source
USFDA

29 devices with a similar name

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Device Recall CryoValve

Model / Serial
Donor #69347, Serial #8022177, Model #PV00
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
The tissue was distributed to one physician in IN.
Product Description
CryoValve, Pulmonary Valve and Conduit
Manufacturer
Cryolife Inc

Device Recall CryoValve, Allograft

Model / Serial
Donor #60741, Model #SGAV10, Serial #783013
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Allograft was distrbuted to one medical facility in CA. No government or foreign accounts involved.
Product Description
Heart-valve, allograft
Manufacturer
Cryolife Inc

Device Recall CryoValve Allograft heart valve

Model / Serial
Model number SGPV00, Serial Number: 7291867, Donor #55899
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
The unit was distributed to one Hospital facility in IN. There are no foreign or government accounts involved.
Product Description
CryoValve Allograft heart valve
Manufacturer
Cryolife Inc

Device Recall CryoValve Allograft heart valve

Model / Serial
Model number PV00, Serial Number: 7255205, Donor #56190
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
One unit was distributed to one Hospital facility in NY. There are no foreign or government accounts involved.
Product Description
CryoValve Allograft heart valve
Manufacturer
Cryolife Inc

Device Recall Cryovalve(R) SG Pulmonary Human Heart Valve

Model / Serial
Serial Number 10988203
Product Classification
Cardiovascular Devices
Device Class
Unclassified
Implanted device?
Yes
Distribution
AR, OH
Product Description
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Manufacturer
CryoLife, Inc.

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Disclaimer

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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