| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00488-1 |
| Product Name/Description |
Biosense Webster PENTARAY NAV and PENTARAY NAV eco Catheters (used for electrophysiological mapping of the heart)
Catalogue Numbers: D128201, D128202, D128203, D128204, D128205, D128206, D128207, D128208, D128209, D128210, D128211, D128212
All Lot Numbers affected
ARTG numbers: 129479, 203362, 231772 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, 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”.
If excessive force is applied on the entangled catheter spine, there is a potential for parts to detach and embolise inside the patient’s body, which may lead to serious complications like stroke, transient ischemic attack, myocardial infarction or pulmonary embolism. The likelihood of these serious complications remains low. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Johnson and Johnson Medical (JJM) are providing users with an updated IFU to follow to ensure the products are not used in patients with prosthetic valves. This action has been closed-out on 10/05/2017. |
| Contact Information |
02 9815 4218 - Biosense Webster |