Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid… — Class I medical device recall Z-1585-2025
Ongoing recall by Conavi Medical Inc., reported 2025-04-30, distributed in GA, NJ, NY, OH. Due to manufacturing issues there is a potential for the catheter sheath to detach.
| Recall number | Z-1585-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Conavi Medical Inc., Toronto, N/A, Canada |
| Recall initiated | 2025-03-12 |
| Classified | 2025-04-23 |
| Reported by FDA | 2025-04-30 |
| Distributed | GA, NJ, NY, OH |
| Countries outside the US | CA, CN |
| Quantity | 685 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00628055603054 |
| Lot numbers | 2024-06, 2025-03, 2025-04, 2025-05, 2025-06, 230902, 240202, 240302, 240402, 240502 |
| Model numbers | TA-06-0001 |
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 for recall
Due to manufacturing issues there is a potential for the catheter sheath to detach.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1585-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.