device · product 1 of 1
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.
- Recall number
- Z-1585-2025
- Initiated
- March 12, 2025
- Classification
- Class I
- Status
- Ongoing
- Recalling firm
- Conavi Medical Inc.
- Quantity
- 685
App-derived interpretation
Unknown
Due to manufacturing issues there is a potential for the catheter sheath to detach.
Official device-enrichment evidence · Sourced
Process control
Inspect official wording and provenance
Reason for recall
Due to manufacturing issues there is a potential for the catheter sheath to detach.
Code information
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 pattern
US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries of: Canada and China