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.

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

On 03/12/2025, the firm sent via email an "URGENT: MEDICAL DEVICE VOLUNTARY RECALL" Letter informing customer that the firm has become aware that the sheath of the Novasight Hybrid catheter detached and left in the patient's body during a clinical case but was retrieved during the procedure. Customers are instructed to: Customers shall stop/cease use of the affected the Novasight Hybrid catheters and remove them from service and return immediately to Conavi Medical Inc. This applies to all Novasight Hybrid catheters shipped to U.S.A. regardless of expiry dates. Acknowledge receipt of this recall notification by completing and returning the "Acknowledgement" section of this notification by email to: [email protected]. For questions or assistance - Contact information: Director of Product Management and Marketing Telephone # (416)-483-0100 Ext 109, Email: [email protected] Days/Hours Available for calls: Monday through Friday, 9:00 AM to 4:30 PM Eastern Time.