FDA Warns of 49 Deaths Tied to Faulty Heart Pumps
The Food and Drug Administration (FDA) has issued a Class I recall, the most serious type of recall for medical devices, for the Impella Left Sided Blood Pumps due to the risk of the device potentially puncturing a wall of the heart. This issue has been linked to 49 deaths and over 100 serious injuries globally. The manufacturer, Abiomed, is said to have failed to notify the FDA about the perforation risk more than two years prior, a step that could have led to earlier warnings to hospitals and doctors.
Abiomed has faced criticism for not only the delayed reporting but also for spending millions of dollars on promoting the Impella heart pump and providing consulting payments to cardiologists and hospitals. Despite these marketing efforts, the FDA's recent action highlights ongoing safety concerns about the device, which is used in patients with life-threatening heart conditions.
The FDA has issued revised warnings for the use of the Impella pumps, which include recommendations such as using imaging when advancing or torquing the pump catheter and exercising special care when inserting the pump in patients with certain high-risk conditions or during active CPR. The recall involves over 66,000 devices in the United States, with additional units in Australia, Canada, France, India, and other countries. These devices were distributed between October 2021 and October 2023. Despite the serious nature of the recall, the FDA is not calling for the removal of the devices but has mandated corrections to mitigate the risks.
