Recall Z-0979-2012 ยท OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Biosense Webster, Inc.
EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation p
| Date | Feb 7, 2012 (initiated Nov 22, 2010) |
| Status | Terminated |
| Reason | Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers. 2. To minimize risk of atrio-esophageal fist |
| Root cause | Labeling design |
| Action | Biosense Webster, Inc. sent an Urgent Field Safety Notice letter dated Novembe 22, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised to continue use of the affected product and that no further action is required on their part. Consignees were advised that the updated IFU can be found at www.jnjgatewayifu.com. Consignees were instructed to contact their local Biosense Webster representative if they have any questions or require additional information. For questions regarding this recall call 9 |
| Quantity | 24,713 units in total |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.