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Arrow International, Inc., Division of Teleflex Medical

9 recalls •
🏥 Medical Devices
• Categories: Other Medical Devices

Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Class I - Dangerous

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Feb 10, 2016 Other Medical Devices Nationwide View Details →

Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Class I - Dangerous

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Feb 10, 2016 Other Medical Devices Nationwide View Details →

Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Class I - Dangerous

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Feb 10, 2016 Other Medical Devices Nationwide View Details →

RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Class I - Dangerous

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Feb 10, 2016 Other Medical Devices Nationwide View Details →

UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Class I - Dangerous

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Feb 10, 2016 Other Medical Devices Nationwide View Details →

FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Class I - Dangerous

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Feb 10, 2016 Other Medical Devices Nationwide View Details →

UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Class I - Dangerous

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Feb 10, 2016 Other Medical Devices Nationwide View Details →

Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Class I - Dangerous

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Feb 10, 2016 Other Medical Devices Nationwide View Details →

FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Class I - Dangerous

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Feb 10, 2016 Other Medical Devices Nationwide View Details →