Recall Z-0946-2009 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
St. Jude Medical Inc
Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, manufactured by St.Jude Medical, Sunnyvale, CA Disposable connecting cable, accessory to the Epicor Cardiac Ablation Control System. The cable is used to connect the Epicor disposable tissue device (UltraCinch or UltraWand) to the Epicor Cardiac Ablation control System.
| Date | Jan 30, 2009 (initiated Dec 9, 2008) |
| Status | Terminated |
| Reason | Firm has received multiple reports of difficulties connecting the product and/or the presence of error code messages occurring with the use of the connecting cable and the Ablation Control System unit. |
| Root cause | Other |
| Action | The firm issued notification by "Urgent Product Recall" letter dated 12/4/2008, to all consignees. The letter describes the issue, potential risk and states that the product should be returned. For additional information, contact St Jude Medical at 800-722-3423. |
| Quantity | 158 units distributed. |
| Distribution | Worldwide - NY, IN, NC, UT, OR, CA, IL, MI, TX, TN, and FL and country of Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080292 | EPICOR ABLATION SYSTEM St Jude Medical, Jul 25, 2008 |