Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.
Publicado el 4 de septiembre de 2013 · Inicio del retiro: 19 de julio de 2013
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
Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication: Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. Additionally, the designation of aspirin and clopidogrel was missing from the following contraindication "
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Distribuidor
- US Distribution including the states of AZ, KY, MO, NC, GA, WI, OR, FL, NY, CA, IL, TN, NV, TX, CO, MA, IA, UT and VA.
- Lote
- Model/Lot Numbers: FA-71400-25 / 9747602 FA-77350-18 / 9749412 FA-77400-20 / 9759088 FA-71500-35 / 9747604 FA-77375-16 / 9744487 FA-77425-16 / 9752788 FA-77300-16 / 9757068 FA-77375-20 / 9757065 FA-77425-20 / 9744123 FA-77325-14 / 9759141 FA-77400-14 / 9757233 FA-77425-20 / 9752438 FA-77325-16 / 9753034 FA-77400-14 / 9768698 FA-77450-18 / 9753033 FA-77325-16 / 9757024 FA-77400-16 / 9743468 FA-77475-20 / 9752787 FA-77325-18 / 9759560 FA-77400-18 / 9751579 FA-77500-20 / 9750678 FA-77350-16 / 9752785 FA-77400-20 / 9755707
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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