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U.S. Department of Health and Human Services

Class 1 Device Recall Novasight Hybrid System

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 Class 1 Device Recall Novasight Hybrid Systemsee related information
Date Initiated by FirmMarch 12, 2025
Date PostedApril 23, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1585-2025
Recall Event ID 96444
510(K)NumberK172258 
Product Classification Catheter, ultrasound, intravascular - Product Code OBJ
ProductBrand 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.
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).
FEI Number 3012198618
Recalling Firm/
Manufacturer		 Conavi Medical Inc.
293 Lesmill Rd
Toronto Canada
Manufacturer Reason
for Recall		Due to manufacturing issues there is a potential for the catheter sheath to detach.
FDA Determined
Cause 2		Process control
ActionOn 03/12/2025, the firm sent via email an "URGENT: MEDICAL DEVICE VOLUNTARY RECALL" Letter informing customer that the firm has become aware that the sheath of the Novasight Hybrid catheter detached and left in the patient's body during a clinical case but was retrieved during the procedure. Customers are instructed to: Customers shall stop/cease use of the affected the Novasight Hybrid catheters and remove them from service and return immediately to Conavi Medical Inc. This applies to all Novasight Hybrid catheters shipped to U.S.A. regardless of expiry dates. Acknowledge receipt of this recall notification by completing and returning the "Acknowledgement" section of this notification by email to: julie@conavi.com. For questions or assistance - Contact information: Director of Product Management and Marketing Telephone # (416)-483-0100 Ext 109, Email: julie@conavi.com Days/Hours Available for calls: Monday through Friday, 9:00 AM to 4:30 PM Eastern Time.
Quantity in Commerce685
Distribution US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries of: Canada and China
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OBJ
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