HeartWare International Heart Pump Subject to FDA Class 1 Recall
Medtronic has announced that the U.S. Food and Drug Administration (FDA) has classified two global voluntary recalls of HeartWare International’s HeartWare Ventricular Assist Device (HVAD) as Class 1 recalls. A class 1 recall is the FDA’s most serious recall category, reserved for situations where there is a reasonable risk of … [Read more...] about HeartWare International Heart Pump Subject to FDA Class 1 Recall
FDA Recalls Medtronic Heart Pump Calling it Life-Threatening
Defective Medtronic Heart Pump Is Taking Lives? Medtronic Life-Threatening Heart Devices. The Medtronic heart pump is an HVAD System which takes over for a failing heart. Basically, the system helps to support individuals with heart diseases while they wait for a heart transplant. Flaws, however, surfaced with the heart device … [Read more...] about FDA Recalls Medtronic Heart Pump Calling it Life-Threatening
