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The How and Why of Medical Device Recalls

Have you ever wondered how and why medical devices get recalled?  The Food and Drug Administration (FDA) regulates approvals and recalls for food, drugs, and medical devices.  While the FDA must be provided with reasonable assurances that every medical device it approves for use is safe and effective, sometimes problems arise. What is the Basis » Read More

Medtronic Recalls Defective Defibrillators

On January 22, 2018, the US Food and Drug Administration (FDA) issued a Class I recall of a group of cardiac defibrillators.  These defective medical devices, manufactured by Medtronic, include their Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs). The FDA has identified this as a Class I recall, which is the most » Read More