Reported Jul 26, 2017 · Terminated
Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic…
Penumbra Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Penumbra Inc. · 1 Penumbra · Alameda, CA · 94502-7610
Is this the product you have?
- 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.
- Lot codes and dates
Lots C00644C00645C00646C00717
- Amount recalled
- 155 units
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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