Device Recall CryoValve

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

Donor #60084, Serial #7769926, Model #PV00 and Donor #55139, Serial #7165235, Model #SGPV00.

Cardiovascular Devices

3

Yes

The allografts were distributed to hospitals located in OK and British Columbia, Canada. There were no government accounts.

CryoValve Allograft, Heart valve