Recall Z-2541-2020 ยท OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Abbott
TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and, when connected to an RF generator, to deliver radiofrequency current to the catheter tip electrode for the purpose of a
| Date | May 22, 2020 |
| Status | Terminated |
| Reason | High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter |
| Root cause | Process control |
| Action | The firm began notifying their consignees by letter on 05/22/2020. The notification reported the high rate of reported complaints for loss of contact force information while using the product, the risk to patient, and recommendations to avoid contact force failures. |
| Quantity | 84104 devices |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.