FDA Elevates Edwards Delivery-System Defect to High-Risk Recall After Patient Death
EW sits 20% above its 52-week low of $72.42 on light trading volume (0.3× avg).
Summary
The FDA escalated its warning on Edwards' Commander M delivery systems to a high-risk recall after three reports of balloons bursting during transcatheter mitral valve procedures, including one patient death and one serious injury. Edwards told customers on October 5 to stop using the affected lots and return them; other lot numbers are unaffected. This follows the FDA's initial alert on Thursday and lands just two weeks after the company won FDA approval for its AUTUS pediatric pulmonary valve, so the safety issue is a fresh negative against an otherwise strong regulatory run. The affected patients are typically unsuitable for open-chest surgery, which raises the severity of any device failure. Shares were down about 0.9% on the news.
At the time of this announcement, EW was trading at $86.74 on NYSE in the Life Sciences sector, with a market capitalization of approximately $50B. The 52-week trading range was $72.42 to $96.29. This news item was assessed with negative market sentiment and an importance score of 7 out of 10. Source: Benzinga.