At Ponder Legal Group, our commitment is to keeping our clients informed about critical medical device safety information. This blog post highlights a recent issue with Impella left-sided heart pumps.

FDA Warns of Potential Risks with Impella Left-Sided Heart Pumps

The U.S. Food and Drug Administration (FDA) has issued a warning regarding Impella left-sided heart pumps. The concern centers on the device's Instructions for Use (IFU) potentially not providing adequate guidance for healthcare professionals treating patients who have undergone transcatheter aortic valve replacement (TAVR).

What's the Problem?

The current IFU may not adequately address the risks associated with the Impella pump interacting with a TAVR stent. This interaction could potentially damage the pump's motor housing, leading to pump failure.

What You Should Do

If you have an Impella left-sided heart pump, it's crucial to discuss this information with your doctor. They can assess your specific situation and determine if any additional monitoring or adjustments are necessary.

Ponder Legal Group: Here to Help

If you've been negatively impacted by an Impella left-sided heart pump, you may have legal options. The lawyers at Ponder Legal Group are experienced in handling medical device cases and can help you understand your rights.

For a complete understanding of this FDA warning, we recommend reading the official announcement:Impella Left-Sided Blood Pumps - Instructions for Use Recall Due to Perforation Risks: https://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-instructions-use-impella-left-sided-blood-pumps-due-perforation-risks?utm_medium=email&utm_source=govdelivery

Ponder Legal Group is dedicated to protecting those harmed by defective medical devices. Contact us today for a free consultation.