Certitude Delivery System by Edwards Lifesciences: Class I Recall – Mold Overflow Defect Which May Obstruct Blood Flow

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An embolism could obstruct blood flow to critical organs, leading to serious injury and/or a need to surgically extract the overflow material from the patient. Severe neurologic, cardiac, limb, renal, or gastrointestinal injury may result.

FDA (United States)

The United States Food and Drug Administration (FDA) is an agency within the Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.