Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.
Publicado el 12 de septiembre de 2012 · Inicio del retiro: 5 de enero de 2012
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
Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant reported that a 5 French Zilver Vascular Stent (part number ZIV5-18-125-8-80 from Lot# CF694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub. After further examination, the user determined that the product was a 6 French Zilver Vascular Stent (part number ZIV6-35
Qué hacer
Voluntary: Firm initiated · Other
Detalles del retiro
- Fabricante
- Cook Ireland Ltd.
- Distribuidor
- Worldwide distribution: USA (nationwide) and country of: Japan.
- Lote
- Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Ireland
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