Edwards Lifesciences Recalls Cardiac Device That May at Risk of Balloon Rupture, Placing Patients at Risk
UNITED STATES – As reported online by finance.yahoo.com, Edwards Lifesciences, a manufacturer of medical devices, issued a recall of its IntraClude intra-aortic occlusion cardiac device amid concerns of balloon ruptures that have caused harm to patients.
Edwards Lifesciences manufactures cardiac devices used in cardiopulmonary bypass procedures. The medical device company recently issued a recall of its IntraClude intra-aortic occlusion cardiac device that the United States Food and Drug Administration (FDA) has categorized as “Class I,” meaning the medical device has the potential to cause serious injuries or death to patients. The FDA has received 22 complaints and reports of 3 deaths related to balloon rupture. The recall includes more than 750 cardiac devices sold throughout the United States.
The Consequences of Balloon Rupture in Cardiac Devices
Patients undergoing cardiopulmonary bypass procedures may require the assistance of a medical device that helps the heart and lung function properly during the procedure. Edwards Lifesciences’ IntraClude intra-aortic occlusion cardiac device is intended to take over the function of a patient’s heart and lungs during a cardiopulmonary bypass procedure. If the balloon ruptures, the IntraClude may fail to work, causing a loss of function to a patient’s heart and/or lungs.
Balloon rupture, which causes the cardiac device to fail, can lead to a longer cardiopulmonary bypass procedure, which can put a significant amount of stress on a patient’s health. Additionally, balloon rupture, which causes the cardiac device to fail, may lead to neurological damage, stroke, embolism, and death. Given the serious nature of injuries associated with the IntraClude cardiac device, Edwards Lifesciences had to recall the product to address the device’s defects and why balloon rupture occurs in some procedures.
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