Edwards Lifesciences Issues Recall of IntraClude Intra-Aortic Occlusion Devices Following Three Deaths
UNITED STATES – According to online news articles published by www.mddionline.com and www.raps.org, Edwards Lifesciences have issued a recall of its IntraClude Intra-Aortic Occlusion Devices following twenty-two complaints and three deaths related to balloon ruptures.
Edwards Lifesciences, a medical device manufacturer, has recalled its IntraClude Intra-Aortic Occlusion devices after the company received twenty-two complaints and learned of three deaths related to balloon ruptures during cardiopulmonary bypass procedures. The IntraClude is intended to assist the heart and lungs so they can function properly during procedures. The total number of medical devices subject to the Edwards Lifesciences recall is 757. The affected medical devices were sold and distributed between May 1, 2017, and February 19, 2019.
The medical device essentially takes over the work of the heart and lungs. Device failure poses a serious risk of harm or death to patients. As such, the United States Food and Drug Administration (FDA) has classified the recall as “Class I,” the most serious of recalls available. Balloon bursting during cardiopulmonary bypass procedures may cause patients to sustain neurological damage, embolism, stroke, and death.
Patients and Health Care Providers Rely on Life-Saving Medical Devices
Cardiopulmonary bypass procedures are successful in many patients. However, successful procedures rely on the proper functioning of medical devices to assist in the procedures. Many medical devices on the market today are not independently tested, but rather are cleared by the FDA when the medical device is substantially similar to a product already on the market. Therefore, some testing is never done on new products to uncover potential device failures.
Given that patients place their lives in the hands of a medical device intended to take over the function of the heart and lungs, such patients should feel confident that the devices are safe and effective for their intended use. Any injury or death linked to a failed medical device can make patients and health care providers feel uncertain when choosing to move forward with a serious medical procedure.
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