The U.S. Food and Drug Administration (FDA) has identified Abiomed’s recently distributed urgent change of instructions affecting several models of the manufacturer’s Impella pumps as Class I, the most serious type. Class I recalls, which include both corrections for use and product removals, are issued in cases where use of the device in question may cause serious injury or death, according to the FDA. FDA emphasized in a notice distributed Friday in its daily digest bulletin that the action pertaining to the Impella pumps is a correction, not a product removal. Abiomed first announced the correction on Dec. 27 for specific Impella models that were distributed between Oct. 10, 2021, and Oct. 10, 2023: Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD. FDA said Abiomed issued what is known as an Urgent Medical Device Correction letter for these devices – a total of 66,390 distributed in the U.S. are affected – because the pump catheter might perforate the left ventricular wall during procedures. This may lead to left ventricular perforation or free wall rupture, hypertension, ischemia or death. According to FDA, 129 serious injuries, and 49 deaths, have been reported in relation to the perforation issue. In its letter, Abiomed asked customers to follow new and revised warnings: Carefully position the pump catheter during procedures Use imaging when advancing or torquing the catheter Use special care when inserting the catheter into patients deemed high risk or who are undergoing active CPR Review updated warnings in the device Instructions for Use Healthcare providers using these devices who have questions should contact Abiomed at (978) 646-1400. Healthcare providers and consumers may report adverse reactions or problems related to these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Image Credit: iQoncept – stock.adobe.com