| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01213-1 |
| Product Name/Description |
Vessix Generator System (portable RF generator used with percutaneous angioplasty balloon catheter to deliever low frequency RF energy into the renal artery)
Material Number: H749RDNS0100
Catalogue Number: RDNS010
Serial Numbers: 42041, 42020, 42011, 42034, 42042, 42035
ARTG Number: 208743 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
An investigation has found that the units manufactured since April 2013 were not manufactured according to specification. This manufacturing issue may cause an electrical short in the generator. The issue could result in excessive RF energy being delivered to the renal artery with intermittent temperature spikes that may range between 86 - 93 degrees C. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are requested to segregate the devices immediately and organise for the return to Boston Scientific. |
| Contact Information |
02 8063 8340 - Boston Scientific Quality Assurance |