FDAFDA · Alimentos y medicamentos·N.º oficial Z-3106-2017
Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device used to occlude the vessel and prevent blood loss as the physician preps for surgery resulting from an SVC tear complication of a lead extraction case. It is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.
Publicado el 4 de octubre de 2017 · Inicio del retiro: 7 de agosto 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
Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Spectranetics Corporation
- Distribuidor
- Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Poland, South Africa, Sweden, Switzerland, and United Kingdom.
- Lote
- Model Number 590-001, Lots FMN17B13A, FMN17C08A, FMN17C28A, FMN17D07A, FMN47D12A, FMN17D19A, FMN17D27A, FMN17E02A, FMN17E23A, FMN17E31A, FMN17E31B, FMN17F06A, FMN17F20A, FMN17F21A, FMN17G12A, FMN17G18A. Additional lots: FMN17H03A, FMN17H04A, FMN17H05A, FMN17H10A, FMN17H12A, FMN17H15A, FMN17H17A, FMN17H29A, FMN17J28A, FMN17K02A.
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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