Class I — Conavi Medical Inc.
| Recalling firm | Conavi Medical Inc. |
|---|---|
| Registered facility | Conavi Medical Inc (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Due to manufacturing issues there is a potential for the catheter sheath to detach. |
| 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 t… |
| Quantity | 685 |
| Distribution | US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries of: Canada and China |
| Initiated | 2025-03-12 |
| Classified | 2025-04-23 |
| Recall number | Z-1585-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Conavi Medical Inc. (Z-1585-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96444/
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