| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01391-1 |
| Product Name/Description |
Eluvia 150mm and Innova 200mm Stent Systems
Multiple Products and Material Numbers
ARTG Numbers: 285061 and 104281 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Boston Scientific is initiating a removal from the market of the150mm Eluvia Drug-Eluting Vascular Stent System and the 200mm Innova Self-Expanding Stent System due to elevated complaint rates for partial stent deployment.
There have been 190 complaints of partial deployment. Partial deployment occurs when the stent is unable to be fully released from the delivery system. Part of the stent can become anchored in the vessel while the rest of the stent remains within the delivery system. The most common reported injury has been additional medical or minor surgical intervention, vessel trauma or prolongation of the implant procedure. However, Boston Scientific has received reports in 14 cases of major surgery to retrieve the stent/delivery system or to correct vascular compromise. |
| Recall Action |
Recall |
| Recall Action Instructions |
Boston Scientific is advising users to inspect stock and quarantine the affected products for return for credit.
This action has been closed out on 17/01/2024 |
| Contact Information |
1800 676 133 - Boston Scientific Customer Service |