Recall Z-1585-2025— Conavi Medical Inc.

Name: FDA recall Z-1585-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-12

Class I · Ongoing

Class I FDA medical device recall by Conavi Medical Inc., initiated 2025-03-12. It names one FDA 510(k) clearance: K172258. Product: 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: Due to manufacturing issues there is a potential for the catheter sheath to detach..

Recalling firm: Conavi Medical Inc.
Classification: Class I
Status: Ongoing
Initiated: 2025-03-12
Firm location: Toronto, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K172258 — Novasight Hybrid SystemConavi Medical, Inc.·cleared 2018-04-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.