IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X ...



IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated.
Components:
Units Affected:    6,552
Recall Date:    May 14, 2019
Mfg:
Edwards Lifesciences, LLC
Mfg Country:
United States
Recall ID:    82870
Product ID:    172949
Enforcement Date:    Jun 19, 2019
Last Published:    Jun 24, 2020

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Emert Number:    Z-1705-2019
Emert Status:    Announced