FDAMay 14, 2019device

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 ascend...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device will need to be exchanged or operative strategy would need to change, including placement of an external cross-clamp, conversion to an open procedure, or performing the procedure under fibrillation.

What to do

FDA enforcement status: Terminated

Brands named

edwards lifesciencesedwards

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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