Inside the Gap Between an Early Alert and a Classified RecallThe agency's Early Alert on the introducer issue appeared in mid June, days after the manufacturers wrote to hospitals. Nobody should delay or decline urgent cardiac care based on a device recall. Impella support is used in situations where the alternative is often worse, and the FDA has not restricted its use. An Early Alert is a preliminary public notice the FDA issues while it is still reviewing a potentially high-risk device problem. Clinicians are advised to watch for blood loss at the sidearm and hub of the introducer sheath, and to consider a device exchange or repositioning sheath if leakage appears.