Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product
Summary
The FDA issued a Class I for Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Mo by Conavi Medical Inc.. Reason: Due to manufacturing issues there is a potential for the catheter sheath to detach..
Details
Source
Device Recall
External ID
Z-1585-2025
Action Date
2025-04-30
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: 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).
Quantity Affected: 685
Reason for Recall
Due to manufacturing issues there is a potential for the catheter sheath to detach.
Distribution
US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries of: Canada and China
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-12
Company
Toronto, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 193 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Conavi Medical Inc. has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Conavi Medical Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Conavi Medical Inc. have FDA actions?
Conavi Medical Inc. has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1585-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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