The manufacturer is currently updating the catheter’s IFU to clarify the risk factors for potential thrombus formation or deposition and to offer recommendations. In a company statement, Abiomed told ...

Previous issues include perforation risks with the Impella catheter itself (which was classified as a Class I recall by the FDA in March 2024, linked to 49 deaths and 129 serious injuries) ...

On Dec. 27, 2023, Abiomed sent affected customers an Urgent Medical Device Correction letter with updated warnings that stress careful positioning of the Impella pump catheter under image guidance.

Abiomed updated warnings on more than 60,000 Impella Left Sided Heart Pumps because the device might cut the wall of the heart’s left ventricle, the FDA said March 21. After 129 serious injuries ...

Cardiac Arrest and Sepsis. Patients treated with Impella also had higher rates of cardiac arrest (33.9% vs 26.8%; HR, 1.310; 95% CI, 1.135-1.511; P < .001) and sepsis (14.6% vs 12.3%; HR, 1.410 ...

The Impella is a type of heart pump that can help people with certain cardiovascular conditions. ... a doctor removes the catheter. Vs. left ventricular assist devices (LVADs) ...

"Catheter ablation of ventricular tachycardia in high-risk patients is associated with high mortality and frequent recurrence," Sroubek noted. The Impella 5.0 and 5.5 devices are high-flow axial ...

The Impella ECP heart pump has completed the first stage in its U.S. Food and Drug Administration (FDA) early feasibility study (EFS) and the FDA has granted 510(k) clearance to the Impella XR sheath.

The Impella RP Flex is inserted through the jugular vein in the neck, as opposed to up through blood vessels in the thigh with its predecessor, the Impella RP. The catheter-based device is then ...

The Food and Drug Administration (FDA) has issued a Class I recall, the highest-level alert, for heart pumps that have been linked to nearly 50 deaths. Impella heart pumps are used for short term ...

The Impella 5.5 with SmartAssist pulls blood from the left ventricle through an inlet area near the tip of the pump and expels blood from the catheter into the ascending aorta.