| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00519-1 |
| Product Name/Description |
PentaRay Nav Catheter (used for multiple electrode electrophysiological mapping of cardiac structures in the heart)
Product codes: D128201, D128202, D128204, & D128205
All lot numbers
ARTG number: 203362 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
Biosense Webster, a division of Johnson and Johnson Medical, 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. To date, with regard to the affected products, Biosense Webster has not received any reports of: (i) a complete tip separation from the shaft; or (ii) patient injuries or adverse events as a result of a partial tip separation from the shaft. There is no concern for patients who have already been successfully mapped with the affected products. The incidence rate of the tip to shaft separation is 0.11 % . Partial separation exposes the internal components of the catheter to intracardiac blood and could lead to thrombus formation and could become a potential embolic source. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to immediately check their inventory to quarantine if there are affected products. |
| Contact Information |
1800 252 194 - JJM Customer Serivce |