Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18785 |
| Brand Name: | Biosense Webster nMARQ Circular Irrigated Catheter |
| Model: | D132214 |
| Affected: | all lots |
| Software version: | |
| Recalling Organisation: | Johnson & Johnson (New Zealand) Limited 507 Mt Wellington Highway Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 922 638 |
| Manufacturer: | Biosense Webster Inc |
| Issue: | The manufacturer has received an increased number of complaints related to a low temperature measurement anomaly at electrodes of the nMARQ® Circular Irrigated Catheter. During the same time period, has also received three reports of deaths of patients who were treated with the nMARQ® Circular Irrigated Catheter. Two of these cases were confirmed to be caused by Atrio-Oesophageal Fistula. No direct link could be confirmed between the low temperature issue and the Atrio-Oesophageal Fistula as it was detected in only one of the two confirmed cases. Therefore, the low temperature issue may be a secondary risk factor as it may affect power titration and delivery during radio frequency ablation.As a result of these issues, Biosense Webster is recalling the nMARQ® Circular Irrigated Catheter and is conducting a full investigation. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 2/7/2015 |
