FDAFDA · Food and drugs·Recall number Z-2702-2017
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.
Published July 26, 2017 · Recall initiated: June 9, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Penumbra Inc.
- Distributor
- 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
- Lot
- Lots C00644, C00645, C00646, C00717
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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