Hey folks, here's some important health news you should know about! 🩺
The U.S. Food and Drug Administration (FDA) has just issued its highest-level alert for a heart pump that's been linked to 49 deaths and 129 injuries. 😰
The device in question is the Impella heart pump, a tiny gadget designed to support patients' hearts during high-risk surgeries or after serious heart attacks. Think of it like a temporary sidekick for your heart when it needs some extra help! ❤️🩹
But here's the catch: if used incorrectly, this device can pierce a wall in the heart's left ventricle—the part that pumps oxygenated blood throughout your body. 🚨 That can lead to serious complications like hypertension, lack of blood flow, and even death.
The FDA's alert covers over 66,000 devices supplied in the U.S. since October 2021. They've labeled this as the \"most serious type of recall,\" so it's a big deal.
Back in 2008, the Impella pump got FDA approval. But in October 2021, Abiomed, the company behind the pump, issued a technical bulletin on how to use it correctly to avoid these dangerous issues. Unfortunately, they didn't inform the FDA about this notice within the required 10 days. 😕
In early 2023, the FDA discovered this during an inspection and has since taken action. They've issued a warning letter to Abiomed, prompting new instructions and label warnings for the heart pump.
Johnson & Johnson MedTech, which now owns Abiomed, says they're working on improving processes as part of the company's full integration.
So what does this mean for us? If you or someone you know is scheduled for heart surgery or treatment involving a heart pump, it's super important to talk to your doctor about this news. Knowledge is power! 💪
Stay safe and take care of your hearts, amigos! ❤️
Reference(s):
U.S. FDA issues highest alert for a heart pump linked to 49 deaths
cgtn.com
