Device Recall CryoValve

Donor #60741, Model #SGAV10, Serial #783013

Cardiovascular Devices

3

Yes

Allograft was distrbuted to one medical facility in CA. No government or foreign accounts involved.

Heart-valve, allograft

Model number SGPV00, Serial Number: 7291867, Donor #55899

Cardiovascular Devices

3

Yes

The unit was distributed to one Hospital facility in IN. There are no foreign or government accounts involved.

CryoValve Allograft heart valve

Model number PV00, Serial Number: 7255205, Donor #56190

Cardiovascular Devices

3

Yes

One unit was distributed to one Hospital facility in NY. There are no foreign or government accounts involved.

CryoValve Allograft heart valve

Serial Number 10988203

Cardiovascular Devices

Unclassified

Yes

AR, OH

Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO

Donor #61266, Serial # 7701969, Model #AV00; Donor #63307, Serial #7899279, Model # SGAV00; Donor #64489, Serial #7869356, Model # SGPV00; Donor #65674, Serial # 7957300 Model #SGPV00; Donor #64879, Serial # 7883273, Model #SGPV00; Donor #64697, Serial #7876274, Model #PV00.

Cardiovascular Devices

3

Yes

Tissue products were distributed to Medical facilities located in CA, MD, ME and SD. There were no foreign or government accounts.

CryoValve Allograft, heart valve