"FDA Alerts on Abiomed Left-Sided Impella Pumps Linked to 49 Deaths"
The FDA issued a high-level alert about the Impella heart pump, associated with 49 deaths and numerous serious injuries, due to potential risks if used incorrectly. The device's manufacturer, Abiomed, is providing updated instructions to physicians on proper usage, including positioning the pump's catheter and using imaging during procedures. Although classified as the most serious type of recall, the device will remain on the market. Johnson & Johnson MedTech, which acquired Abiomed, emphasized its commitment to patient safety and quality. The FDA is investigating the reported deaths, and the company has faced scrutiny for not promptly submitting updated guidance to the agency.
