Device Recall CryoValve

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

Aortic Valve & Conduit, Donor #29976, Serial #6212891, Model #AV00 and Pulmonary Valve & Conduit Donor #51562, Serial #7093095, Model #PV00

Cardiovascular Devices

3

Yes

Heart allografts were distributed to two hospitals in OH and Quebec, Canada.

CryoValve Allograft, Heart valve.

Aortic Valve & Conduit, Donor #34695, Serial #6356206, Model #AV00 and Pulmonary Valve & Conduit, Donor #34695, Serial #6356214, Model #PV00.

Allografts were distributed to 2 physicians in NY and MS. Allografts were implanted.

CryoValve Heart-valve, allograft