Z-1585-2025 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.

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

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).