Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Des
FDA device recall Z-1585-2025 · posted 2025-04-23 · Open, Classified
Recall details
- Recalling firm
- Conavi Medical Inc.
- Reason for recall
- Due to manufacturing issues there is a potential for the catheter sheath to detach.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- OBJ
- Quantity affected
- 685
- Distribution
- US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries of: Canada and China
- Date initiated
- 2025-03-12
- Date posted
- 2025-04-23
- Location
- Toronto, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Novasight Hybrid System (K172258) | Conavi Medical, Inc. | 2018-04-27 |