Recall Z-1902-2025 ยท DQO Catheter, Intravascular, Diagnostic
Cook Incorporated
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coating. Refer to the product label for product specifications (e.g., catheter length, distal curve configuration).
| Date | Jun 16, 2025 (initiated May 15, 2025) |
| Status | Open, Classified |
| Reason | Cook Medical identified that catheters supplied in the affected device lots may experience tip separation. |
| Root cause | Process change control |
| Action | Cook Medical issued an URGENT: MECIAL DEVICE RECALL notice to its consignees on 05/15/2025 via Fed-Ex Standard Overnight mail. The notice explained the reason for the recall, risk to health, and requested the following actions be taken: "Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to rec |
| Quantity | 26986 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173289 | Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Cook Incorporated, Nov 15, 2017 |