FDAFDA · Alimentos y medicamentos·N.º oficial 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.
Publicado el 26 de julio de 2017 · Inicio del retiro: 9 de junio de 2017
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Penumbra Inc.
- Distribuidor
- 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
- Lote
- Lots C00644, C00645, C00646, C00717
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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