FDA Medical devices recall ·
Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1585-2025
- Date
- (initiated March 12, 2025)
- Company / brand
- Conavi Medical Inc.
293 Lesmill Rd, Toronto, N/A, Canada - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 685
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due to manufacturing issues there is a potential for the catheter sheath to detach.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries of: Canada and China
States: Georgia New Jersey New York Ohio
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1585-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.