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FDAJune 9, 2017device

Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onset. Patients who ar...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death.

What to do

FDA enforcement status: Terminated

Brands named

penumbra

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onset. Patients who ar... — Recall Details · AllClear