| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01325-1 |
| Product Name/Description |
Sensei X Robotic Catheter System
Model Numbers: 02057 and 08257
ARTG Number: 157314 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
There is a potential for the Set-Up Joint Sub-assembly to become loose relative to the operating table. Should this issue occur during clinical use, it may potentially result in uncontrolled catheter motion.
Uncontrolled catheter motion could result in cardiac tamponade or perforation of the heart. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The Customer is requested to ensure that the RCM is secure and tightly connected to the patient table before starting a procedure and check that all clamps are properly tightened. In addition, ensure that the RCM does not come into contact with other laboratory equipment, as this may produce forces capable of dislodging the RCM. In the event the clamp is found to be loose, customers are advised not use the system and to contact St.Jude Medical immediately. This action has been closed-out on 14/07/2016. |
| Contact Information |
02 9936 1200 - St Jude Medical Australia Pty Ltd |