FDA Announces Recall for Penumbra Revascularization Device

The FDA updated the status of a voluntary field removal notice for Penumbra’s 3D revascularization device, designating it as a Class I recall.

The device is indicated for revascularization of patients with acute ischemic stroke. The company identified a problem with raw material components of the device’s delivery wire, which could lead to breakage of the wire.

In June, Penumbra distributed an urgent voluntary field removal notice instructing customers to remove affected units, because the issue, left unchecked, could lead to death or serious injury.