FDA: Class I Recall for IntraClude Intra-Aortic Occlusion Device
The device, used during cardiopulmonary bypass, was recalled by the manufacturer in May after reports of balloon rupture.
The US Food and Drug Administration has issued an alert for the IntraClude intra-aortic occlusion device (Edwards Lifesciences), which was recalled by the manufacturer in mid-May following reports of balloon rupture.
The company says it has received 22 complaints that the device, used during cardiopulmonary bypass to occlude and vent the ascending aorta, has ruptured or punctured during procedures. Three patients in whom the device malfunctioned have died.
“The IntraClude balloon bursting may cause serious adverse health consequences related to increased time the patient is on cardiopulmonary bypass, including neurological damage, embolism, stroke and death,” the FDA notes in a MedWatch safety alert.
The agency has classified the recall as Class I, its most serious category.
The action affects 757 devices distributed in the United States between May 1, 2017, and February 19, 2019. Additional details on the model and lot numbers are available online.
US Food and Drug Administration. Edwards Lifesciences recalls the IntraClude intra-aortic occlusion device due to risk of balloon rupture. Published on: July 1, 2019. Accessed on: July 2, 2019.