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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
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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 number 87732, Serial number 8895131
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Hospitals in DE, TN
Product Description
CryoValve, Aortic Valve & Conduit
Manufacturer
CryoLife, Inc.
Device Recall CryoValve
Model / Serial
Donor number 87732, Serial number 8895391
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Hospitals in DE, TN
Product Description
CryoValve, Pulmonary Valve & Conduit
Manufacturer
CryoLife, Inc.
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
24 more
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