Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26009 |
| Brand Name: | PentaRay High Density Mapping Catheter |
| Model: | |
| Affected: | Product codes: D128201, D128202, D128203, D128204, D128205, D128206 - 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 |
| Brand Name: | PentaRay NAV eco High-density Mapping Catheter |
| Model: | |
| Affected: | Product codes: D128207, D128208, D128209, D128210, D128211, D128212 - 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 received complaints that a PENTARAY ® Catheter had become entrapped in the cardiac valvular apparatus while the physician was attempting to create an electroanatomic map, leading to the need for surgical intervention for removal. |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/5/2020 |
