Edwards Lifesciences Issues Recall of More than 700 of Its IntraClude Intra-Aortic Occlusion Device
UNITED STATES – According to an online news article published by www.legalscoops.com, Edwards Lifesciences has recalled more than 700 IntraClude Intra-Aortic Occlusion Devices following 22 complaints and 3 reported deaths associated with balloons rupturing.
Edwards Lifesciences is a medical device company that manufactures various products used in heart-related medical procedures, including the IntraClude Intra-Aortic Occlusion Device. Because of recent reports of 22 complaints and 3 deaths related to balloon ruptures, the company has recalled more than 700 of its IntraClude Intra-Aortic Occlusion Devices.
The IntraClude Intra-Aortic Occlusion Device is used in cardiopulmonary bypass procedures to assist surgeons in blocking and venting (occluding) the aorta, allowing surgeons to have a better assessment of a person’s heart without interfering with other vital organs.
The IntraClude devices have a balloon that must inflate to allow venting of the aorta. Recent reports indicate that the balloon on many IntraClude devices has been rupturing, posing a risk of harm to patients. Proper functioning of the balloon is essential for the entire device to work. The consequences to patients of the IntraClude device’s balloon rupturing include embolism, neurological damage, stroke, and death.
According to Edwards Lifesciences, if a balloon ruptures during a procedure, “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.”
The United States Food and Drug Administration (FDA) has categorized the IntraClude recall as Class I, which is the most serious of recalls, and means that a medical device has the potential to cause a patient to sustain serious injuries or death.
Edwards Lifesciences’ recall of the more than 700 IntraClude devices follows another recall in July of the company’s Sapien 3 Ultra replacement heart valve. The company informed surgeons that they must follow the device’s instructions closely to avoid a balloon bursting during a procedure. A burst balloon makes it challenging for surgeons to retrieve the delivery system.
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