FDA Issues Alert over Heart Pump Tied to Deaths

FDA Alert on Heart Pump Tied to Fatalities

The FDA has recently raised an alert concerning a heart pump device linked to a series of deaths. The device has been under scrutiny due to mounting complications that have caused severe heart wall perforations.

Critical Delay in Notifying Complications

The FDA faulted the manufacturer for delayed reporting of the escalating issues related to the device, with increasing reports of severe side effects.

• The device's usage led to fatal consequences
• Severe heart wall perforations have been reported