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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 9 of 9 Results
Related Medical Device Recalls
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Z-1055-2016 - FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow® IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole ... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
Z-1056-2016 - Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow® IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation,... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
Z-1057-2016 - FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow® IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole a... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
Z-1058-2016 - Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow® IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation,... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
Z-1063-2016 - Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow® IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflati... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
Z-1060-2016 - UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow® IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflat... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
Z-1061-2016 - RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow® IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation,... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
Z-1062-2016 - Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow® IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflat... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
Z-1059-2016 - UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow® IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflat... 1 03/11/2016 Arrow International, Inc., Division of Teleflex Medical Inc.
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