FDAFDA · Alimentos y medicamentos·N.º oficial Z-2155-2014
CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy 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. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
Publicado el 20 de agosto de 2014 · Inicio del retiro: 23 de mayo de 2014
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 the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Cardiovascular Systems, Inc.
- Distribuidor
- Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,and TX.
- Lote
- 100573, 100575, 100674, 100676, 100678, 100680.
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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