The U.S. Food and Drug Administration (FDA) issued a high-risk early alert after Edwards Lifesciences Corp. (NYSE:EW) recalled specific lots of its Commander M delivery systems due to reports of balloons bursting during procedures, resulting in one death and a serious injury.

Recall Of Commander M Delivery Systems

The delivery systems help implant a replacement mitral heart valve through blood vessels, bypassing the need for open-chest surgery.

However, the company received three distinct reports of balloons bursting when inflated during the procedure.

Severe Health Risks

Such bursts can lead to embolisms or trap the device inside the guide sheath. Removing a stuck device often requires additional surgical intervention.

Because patients receiving these valves are typically deemed unsuitable for surgery, these specific complications carry a severe risk of death or serious adverse health consequences.

Recommended Customer Actions

On October 5, the medical device maker instructed customers to stop using the affected lots immediately. Facilities must locate and remove the impacted products from their inventory.

Clinical staff must coordinate with company representatives to return the recalled products. Units bearing other lot numbers are not impacted by the recall and remain safe to use.

EW Price Action: Edwards Lifesciences shares were down 0.86% at $87.34 at the time of publication on Friday, according to market data.