FDA Initiates Class 1 Recall for Abiomed Impella CP Introducer Kit

The FDA has issued a Class 1 recall for Abiomed's 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. The recall is due to a risk of thrombus formation during extended use, which could lead to difficulties with the device or observation of blood clots. Affected units are to be quarantined and returned as per instructions issued in May 2026.