Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Recalled by Conavi Medical Inc. Due to Due to manufacturing issues there is a potential...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Conavi Medical Inc. directly.
Affected Products
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.
Quantity: 685
Why Was This Recalled?
Due to manufacturing issues there is a potential for the catheter sheath to detach.
Where Was This Sold?
This product was distributed to 4 states: GA, NJ, NY, OH
About Conavi Medical Inc.
Conavi Medical Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report