FDAFDA · Alimentos y medicamentos·N.º oficial Z-1959-2012
CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree Orbital PAD system is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
Publicado el 18 de julio de 2012 · Inicio del retiro: 18 de junio 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
CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Cardiovascular Systems, Inc.
- Distribuidor
- Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX.
- Lote
- Lot s: 59887, 59888, 61516, and 61517.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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