A journalist and publisher, John A. Jenkins, co-creator of FOIAengine, recently published a piece about the Impella Heart Pump recall concerning dozens of deaths. 

In-Depth Analysis Reveals Increased Risks with Impella Heart Pump Devices

Put simply, a study found a substantial – 65% higher – fatality rate than what the FDA recall notes. PoliScio Analytics and Redica Systems examined data suggesting the scope is beyond the figures FDA disclosed.

More Deaths Possibly Related to the Impella Heart Pumps

The Redica Systems research puts the death toll associated with the Impella devices over the last 24 months stands at 81. The March recall noted 49 deaths:

“Abiomed is recalling its Impella Left Sided Blood Pumps because the pump catheter may perforate (cut) the wall of the left ventricle in the heart. During operations, the Impella device could cut through the wall of the left ventricle.

The use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death.

There have been 129 reported serious injuries, including 49 reports of death.”

This discrepancy highlights potential gaps in the regulatory oversight and data transparency concerning medical devices. To us, it is also a potential indicator of how plaintiffs may avoid preemption.

If you or a loved suffered after use of a heart pump or the Impella Heart Pump recall impacted you, please contact us today.