Conavi Medical Inc. recalls Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Cat…

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

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.

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: julie@conavi.com. For questions or assistance - Contact information: Director of Product Management and Marketing Telephone # (416)-483-0100 Ext 109, Email: julie@conavi.com Days/Hours Available for calls: Monday through Friday, 9:00 AM to 4:30 PM Eastern Time.

• FDA enforcement recordOfficial FDA database entry for Z-1585-2025
• FDA 510(k) clearance · K172258The device's official FDA premarket clearance record
• FDA device classification · OBJOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1200The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Conavi Medical Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.