Maquet Datascope Corp - Cardiac Assist Division

System 98 - Part Numbers 0998-00-0446-xx, 0998-UC-0446-xx;  System 98XT - Part numbers 0998-00-0479-xx, 0998-UC-0479-xx ;  CS100i- Part numbers 0998-UC-0446Hxx, 0998-UC-0479Hxx;  CS100 - Part numbers 0998-00-3013-xx, 0998-UC-3013-xx;  CS300 - Part numbers 0998-00-3023-xx, 0998-UC-3023-xx

General Hospital and Personal Use Devices

2

No

Worldwide Distribution

Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; || Manufactured by Datascope Corp., 1300 MacArthur Blvd., Mahwah, NJ 07430 || The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloon. It provides temporary support to the left ventricle via the principle of counterpulsion. The IABP is placed in the descending aorta, via the principe of counterpulsation. The IABP is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the IABP is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The CS300 has the additional capability to automatically calibrate a fiber-optic pressure sensor placed in the tip of the intra-aortic balloon. The IABP will recalibrate every 2 hours or sooner should the patient or environmental conditions change. The target populations are adult and pediatric. The IABP is intended for use in the health care facility setting.

IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) and approximately 104 countries.

Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.

Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83

Cardiovascular Devices

2

No

Worldwide Distribution- Nationwide Distribution including Puerto Rico.

Cardiosave Hybrid and rescue IABP

0998-00-0800-31 0998-UC-0800-31 0998-00-0800-32 0998-UC-0800-33 0998-00-0800-33 0998-UC-0800-52 0998-00-0800-34 0998-UC-0800-53 0998-00-0800-35 0998-UC-0800-55 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55.   CARDIOSAVE Hybrid IABPs serviced with a new/replacement power supply after August 19, 2014 are not affected.

Cardiovascular Devices

2

No

US Nationwide distribution

Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

Sensation 7 fr.34 cc IAB Demonstration Unit  0684-DC-0433 0684-DO-0433 0684-DC-0469 0684-DO-0469  Sensation 7 Fr. 40 cc IAB Demonstration Unit 0684-DC-0434 0684-DO-0434 0684-DC-0470 0684-DO-0470  Sesnsation Plus 7.5 Fr. 40cc IAB Demonstration Units  0684-DC-0567 0684-DO-0567 0684-DC-0568 0684-DO-0568  Sensation Plus 7.5 Fr. 50cc IAB Demonstration Units 0684-DC-0575 0684-DO-0575 0684-DC-0576 0684-DO-0576  Sensation Plus 8 Fr. 50 cc IAB Demonstration Unit 0684-DC-0272 0684-DO-0272

Cardiovascular Devices

2

No

Worldwide Distribution

CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx || An electromechanical system used to inflate and deflate intra-aortic balloons.