FDA Issues High-Level Alert for Impella Heart Pumps Linked to 49 Deaths
Despite the recall, the FDA allows continued use of the device, urging adherence to updated safety guidelines.
- The FDA has issued a Class I recall, the highest-level alert, for Impella heart pumps after they were linked to 49 deaths and over 100 serious injuries.
- Despite the risks, the FDA permits the continued use of the Impella device, with updated instructions for safer operation.
- Abiomed, the manufacturer, did not initially report the risk of heart perforation to the FDA, violating agency protocols.
- More than 66,000 Impella devices have been recalled in the U.S., with new warnings added to the device's labeling.
- Health professionals and consumers are encouraged to report any adverse events related to the Impella pumps on the FDA’s MedWatch site.
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