THOR

Model Catalog: ZTA-DE-26-104 (Lot serial: ALL); Model Catalog: ZTA-D-46-211 (Lot serial: ALL); Model Catalog: ZTA-D-44-211 (Lot serial: ALL); Model Catalog: ZTA-D-42-204 (Lot serial: ALL); Model Catalog: ZTA-D-40-197 (Lot serial: ALL); Model Catalog: ZTA-D-40-147 (Lot serial: ALL); Model Catalog: ZTA-D-38-197 (Lot serial: ALL); Model Catalog: ZTA-D-36-190 (Lot serial: ALL); Model Catalog: ZTA-D-34-190 (Lot serial: ALL); Model Catalog: ZTA-D-32-160 (Lot serial: ALL); Model Catalog: ZTA-D-30-160 (Lot serial: ALL); Model Catalog: ZTA-P-46-233 (Lot serial: ALL); Model Catalog: ZTA-P-46-179 (Lot serial: ALL); Model Catalog: ZTA-P-46-152 (Lot serial: ALL); Model Catalog: ZTA-P-46-125 (Lot serial: ALL); Model Catalog: ZTA-P-44-233 (Lot serial: ALL); Model Catalog: ZTA-P-44-179 (Lot serial: ALL); Model Catalog: ZTA-P-44-125 (Lot serial: ALL); Model Catalog: ZTA-P-42-225 (Lot serial: ALL); Model Catalog: ZTA-P-42-173 (Lot serial: ALL); Model Catalog: ZTA-P-42-121 (Lot serial: ALL); Model Catalog: ZTA-P-40-217 (Lot se

Cardiovascular Devices

ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - DISTAL COMPONENT;ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - PROXIMAL COMPONENT;ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT - PROXIMAL TAPERED COMPONENT

Model Catalog: CA-01500 (Lot serial: 13F17A0104); Model Catalog: AK-01000-J (Lot serial: 13F17B0121)

ARROW PNEUMOTHORAX KIT;ARROW-CLARKE THORACENTESIS KIT

Model Catalog: C-UTPT-1400-WAYNE (Lot serial: >100 SEE MFR); Model Catalog: C-UTPT-1020-WAYNE (Lot serial: >100 SEE MFR); Model Catalog: C-UTPTY-1400-WAYNE-112497 (Lot serial: >100 SEE MFR); Model Catalog: C-UTPT-1400-WAYNE-112497 (Lot serial: >100 SEE MFR)

WAYNE PNEUMOTHORAX SET

Catalog number 20010-0000-032. All units manufactured or serviced since August, 2005.

Cardiovascular Devices

3

Yes

Worldwide: USA including states of AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NY, OH, OR, PA, TN, TX, UT, VA, and WA, as well as, countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Qatar, Singapore, Switzerland, Taiwan, UAE, and UK.

Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec Ventricular Assist Device system

Catalog Number 14086-2550-000, bearing serial numbers 10745 or less

Cardiovascular Devices

3

Yes

Class I Recall - Worldwide Distribution --- USA, Canada, Australia, Mexico, Singapore, Taiwan, Thailand, Austria, France, Germany, Israel, and Switzerland.

Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000.