Abiomed Recalls All Lots of 6 Heart Pumps

Abiomed says it is recalling all lots of six models of its Impella heart pumps that are used in patients with a transcatheter aortic valve replacement (TAVR). A company notice says there is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a TAVR, destroying the impeller blades. “This has resulted in low flow from the damaged Impella system,” it says.

The notice says the complication has been seen in 0.7% of patients (27 complaints) with TAVR who were supported by the Impella system from 2016 to the present. Some 25 of the 27 complaints involved the Impella CP, Abiomed says.

The notice says that for patients with TAVR who need hemodynamic support, clinicians should factor the risk into the risk/benefit analysis and are cautioned to position the Impella system carefully as directed in the recall notice.