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 ...

The Impella line, too, received a coronavirus-related FDA nod last year, in the form of an emergency authorization for use in treating COVID-19 patients with right-side heart failure.

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.

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) ...

The recall covers 66,390 devices distributed from October 10, 202, to October 10, 2023, including these devices: Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with ...

Jeff Schrier | The Saginaw NewsDr. Gregory G. Pellizzon, an interventional cardiologist with the Midland office of the Michigan CardioVascular Institute, shows how a catheter with the Impella 2.5 ...

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) ...

May 31, 2024. The Impella® heart pump: from Aachen to the world ...

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 ...

From the press release: Through this latest enhancement, Opsens’ fiber optic sensors will be integrated into the Impella catheter and will allow for further improvements in set-up time, as well ...

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 FDA granted an emergency authorization to Abiomed’s Impella RP heart pump system for COVID-19 patients suffering from right-sided heart failure, including those with a pulmonary embol ...