Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:16673
Brand Name:Biosens Webster PentaRay High Density Mapping Catheter
Model:Product Codes: D128201, D128202, D128204 & D128205
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 identified an issue in the production process of the PentaRay® NAV Catheter that can lead to an insufficient bond of the distal tip to the catheter shaft.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:8/5/2014
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /