Novasight Hybrid Catheter (Conavi) – sheath detachment risk (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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-regist
Brand
Conavi Medical Inc.
Lot Codes / Batch 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).
Products Sold
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).
Conavi Medical Inc. is recalling Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA due to Due to manufacturing issues there is a potential for the catheter sheath to detach.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to manufacturing issues there is a potential for the catheter sheath to detach.
Recommended Action
Per FDA guidance
On 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA, NJ, NY, OH
Page updated: Jan 10, 2026