Device Recall Arrow International, Inc. Intraaortic balloon catheter

Lot/Serial Numbers: MF6079580 MF6100954 MF7033668 MF7086558 MF7086984 MF7097225 MF7097426 MF7118000 MF7118001 MF7128557 and MF8018922.

Cardiovascular Devices

2

No

Worldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.

8 Fr 30cc Narrow Flex IAB Catheter Kit with Generica Adapters || Product Number: IAB-04830-U, Intra-aortic balloon catheter. || The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.

Lot/ASerial Numbers: MF6090318 MF6111511 MF7065955 MF7076255 MF7086556 MF7097114 MF7097115 MF7097226 MF7097227 MF7097228 MF7097427 MF7097470 MF7097471 MF7107861 MF7107862 MF7118045 MF7118046 MF7128470 MF7128508 MF8018724 MF8018813 MF8018996 MF8124303 MF8124304  MF8124304 MF9014426 MF9014444 MF9014446 and MF9014447.

Cardiovascular Devices

2

No

Worldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.

8 Fr 40cc Narrow Flex IAB Catheter Kit with Generic Adapters || Product Number: IAB-04840-U, Intra-aortic balloon catheter. || The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.

Lot/Serial Numbers: MF6122058 MF7065640 MF7076257 MF7076378 MF7097392 MF7118003 MF7118004 MF7118219 MF7128387 MF7128471 MF7128504 MF7128505 MF8018907 MF8018997 MF8030122 MF8039664 MF8039878 MF8040324 MF8040325 MF8040638 MF8050911 MF8061125 MF8061176 MF8061334 MF8061500 MF8061615 MF8071782 MF8072074 MF8082267 MF8082584 MF8092783 MF8092784 MF8093000 MF8093001 MF8103155 MF8103262 MF8103263 MF8124064 MF8124178 MF8124064 MF8124307 and MF8124408.

Cardiovascular Devices

2

No

Worldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.

8 Fr 30cc Ultra 8 IAB, || IAB-05830-U, Intra-aortic balloon catheter. || The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.

Lot/Serial Numbers:  MF8039760 MF8039772 MF8040252 MF8040485 MF8040486 MF8040639 MF8050723 MF8050807 MF8050914 MF8061336 MF8061458 MF8061616 MF8061617 MF8071677 MF8071855 MF8082154 MF8082586 MF8092763 MF8093004 MF8103159 MF8103160 MF8103264 MF8103265 MF8103417 MF8124181 MF8124203 MF8124413 and MF8124414.

Cardiovascular Devices

2

No

Worldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.

7.5 Fr 30cc UltraFlex IAB, || IAB-06830-U, Intra-aortic balloon catheter. || The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.

Lot/Serial Numbers:  MF8029428 MF8029506 MF8029508 MF8030125 MF8030126 MF8039646 MF8039647 MF8039762 MF8039851 MF8040487 MF8040640 MF8050724 MF8061127 MF8061503 MF8071787 MF8072071 MF8082286 MF8082508 MF8093047 MF8103162 MF8103418 MF8103642 MF8113920 MF8114010 MF8124162 and MF8124162.

Cardiovascular Devices

2

No

Worldwide Distribution: USA, Argentina, Australia, Taiwan, Singapore, New Zealand, India, Brazil, Belgium, Korea, Peru, Finland, and Denmark.

7.5 Fr 40cc UltraFlex IAB, || IAB-06840-U, Intra-aortic balloon catheter. || The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.