FDA Issues Highest-Level Alert for Heart Pumps Linked to Nearly 50 Deaths — Recalls Over 66,000 Units
Credit: MedPage Today
The Food and Drug Administration (FDA) has announced a Class I recall, the most serious type of recall, for Impella Left Sided Blood Pumps after they were associated with nearly 50 fatalities.
The advanced medical devices, which are primarily used to assist blood flow in heart ventricles during procedures or after severe cardiac events, have come under scrutiny due to alarming reports of device-induced injuries and deaths.
“Impella Left Sided Blood Pumps are used for short term support of the pumping chambers of the heart (ventricles) during high-risk catheter-based procedures called percutaneous coronary interventions (PCI),” according to FDA.
“Impella Left Sided Blood Pumps also are used when there is ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack (acute myocardial infarction),
