The Food and Drug Administration has now classified a manufacturing defect in catheter introducer kits used with Impella heart pumps as a Class I recall, the agency's most serious category, roughly three weeks after it first warned the public through a preliminary notice.
Federal records show 13 separate recall entries tied to a single event, all posted on the same day and all assigned Class I status. The recall covers introducer kits made by Oscor for Johnson & Johnson's Abiomed unit in 14 French and 23 French sizes, sold both individually and packaged inside Impella pump sets distributed across the United States and roughly three dozen other countries.
