PlainRecalls
FDA Devices Critical 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-re

Reported: April 30, 2025 Initiated: March 12, 2025 #Z-1585-2025

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Conavi Medical Inc.
Units Affected
685
Distribution
US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries of: Canada and China
Location
Toronto, N/A

Frequently Asked Questions

What product 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.. Recalled by Conavi Medical Inc.. Units affected: 685.
Why was this product recalled? ▼
Due to manufacturing issues there is a potential for the catheter sheath to detach.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 30, 2025. Severity: Critical. Recall number: Z-1585-2025.

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