Recall Z-1795-2014 ยท OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Boston Scientific Corporation
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
| Date | Jun 16, 2014 (initiated May 15, 2014) |
| Status | Terminated |
| Reason | Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification. |
| Root cause | Use error |
| Action | Customers were informed of the recall via overnight letter sent on May 15, 2014. |
| Quantity | 968 units total all models |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.