FDAFDA · Alimentos y medicamentos·N.º oficial Z-1585-2025
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.
Publicado el 30 de abril de 2025 · Inicio del retiro: 12 de marzo de 2025
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Due to manufacturing issues there is a potential for the catheter sheath to detach.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Conavi Medical Inc.
- Distribuidor
- US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries of: Canada and China
- Lote
- Model No: TA-06-0001 UDI-DI: (01)00628055603054 Lot number: 230902; Expiration date: 2024-06; Lot number: 240202; Expiration date: 2025-03; Lot number: 240302; Expiration date: 2025-04; Lot number: 240402; Expiration date: 2025-05; Lot number: 240502; Expiration date: 2025-06; and all catheter lots which were expired (See attachment 2a, 2b and 2c for details).
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- Canada
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