Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20076 |
| Brand Name: | Biosense Pentaray Catheters |
| Model: | D128201, D128202, D128203, D128204, D128205, D128206, D128207, D128208, D128209, D128210, D128211, D128212 |
| Affected: | all lot numbers |
| 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: | Biosense PentaRay Catheters |
| Model: | D128201, D128202, D128203, D128204, D128205, D128206, D128207, D128208, D128209, D128210, D128211, D128212 |
| Affected: | all Lot numbers |
| 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: | Biosense Webster is clarifying the contraindication language in the Instructions for Use (IFU) and product labelling for use of this catheter relative to patients with prosthetic valves. The current language in the IFU provides a precaution against use of the PENTARAY® Catheter in patients with prosthetic valves under the contraindication section stating: "[The] use of this catheter may not be appropriate for use in patients with prosthetic valves." The update to the IFU is to clarify the contraindication statement to the following: "Do not use PENTARAY® Catheters in patients with prosthetic valves". |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/4/2016 |
