Penumbra Inc. recalls Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic…

Recall date

June 9, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2702-2017

FDA classification

Class I

Brand / firm

Penumbra Inc.

Sold / distributed

Nationwide Distribution to the following states: AZ, CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WV

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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 are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.