FDA announces recall of all Impella heart pump controllers after 3 deaths - Cardiovascular Business

The FDA has announced a recall of all Impella heart pump controllers following three deaths.

Details from the underlying FDA notice — the specific failure mode, model numbers, timing of the events, and whether the recall is a correction or a removal — are not contained in the source summary provided.

Impella is not a valve device, but it is frequently deployed adjunctively during high-risk TAVR, complex PCI, and post-cardiotomy shock scenarios that intersect directly with structural heart practice.

A controller-level recall affecting all units — as opposed to a specific lot or generation — is unusual and operationally consequential for cath labs and hybrid ORs that rely on Impella for hemodynamic support during structural cases.