BEUDAMED
    FDA Enforcement Class I Ongoing

    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.

    Recall: Z-1585-2025 · Reported April 30, 2025

    Enforcement

    Recall Number
    Z-1585-2025
    Event ID
    96444
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Conavi Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 30, 2025
    Initiation Date
    March 12, 2025
    Classification Date
    April 23, 2025
    Address
    293 Lesmill Rd, N/A, Toronto, N/A, N/A, Canada

    Description

    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.

    Reason

    Due to manufacturing issues there is a potential for the catheter sheath to detach.

    Code Info

    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).

    Distribution

    US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries of: Canada and China

    Quantity

    685