Conavi Medical Inc. recalls Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product De…

Recall date

March 12, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1585-2025

FDA classification

Class I

Brand / firm

Conavi Medical Inc.

Sold / distributed

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

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.