Recall Z-1585-2025 ยท OBJ Catheter, Ultrasound, Intravascular
Conavi Medical Inc.
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
| Date | Apr 23, 2025 (initiated Mar 12, 2025) |
| Status | Open, Classified |
| Reason | Due to manufacturing issues there is a potential for the catheter sheath to detach. |
| Root cause | Process control |
| Action | 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 rec |
| Quantity | 685 |
| Distribution | US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries of: Canada and China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172258 | Novasight Hybrid System Conavi Medical, Inc., Apr 27, 2018 |