Conavi Medical Inc.: Device Recall
Recall #Z-1585-2025 · 03/12/2025
Recall Details
- Recall Number
- Z-1585-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Conavi Medical Inc.
- Status
- Ongoing
- Date Initiated
- 03/12/2025
- Location
- Toronto, N/A, Canada
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 685
Reason for Recall
Due to manufacturing issues there is a potential for the catheter sheath to detach.
Product 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.
Distribution Pattern
US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries of: Canada and China