[pending] Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number:
Pending LLM rewrite. Source: FDA_DEVICE Z-1585-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Due to manufacturing issues there is a potential for the catheter sheath to detach.
The recalled product
- 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
- Manufacturer
- Conavi Medical Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Model No: TA-06-0001 UDI-DI: (01)00628055603054 Lot number: 230902
- Expiration date: 2024-06
- Lot number: 240202
- Expiration date: 2025-03
- Lot number: 240302
- Expiration date: 2025-04
- Lot number: 240402
- Expiration date: 2025-05
- Lot number: 240502
- Expiration date: 2025-06
- and all catheter lots which were expired (See attachment 2a
- 2b and 2c for details).
Distribution
Distributed in 4 states:
- GA
- NJ
- NY
- OH
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