Recall Z-1209-2015 ยท OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Boston Scientific Corp
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofreq
| Date | Mar 2, 2015 (initiated Feb 3, 2015) |
| Status | Terminated |
| Reason | Reports of formation of char adherent to the proximal part of the distal tip electrodes |
| Root cause | Device Design |
| Action | Customer notification letters were sent by overnight mail on February 10, 2015. |
| Quantity | 14 units |
| Distribution | Distributed in Germany, Great Britain, and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.