| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01016-1 |
| Product Name/Description |
Lotus Valve System (transcatheter aortic valve implantation (TAVI) system)
Product numbers : H749LTV230, H749LTV250, H749LTV270
Affected lot numbers remaining in the market : 18948721, 18948723, 18948521
ARTG Number: 260448 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
Boston Scientific is undertaking a recall of the Lotus Valve System to remove units from the field that were manufactured prior to a component related change made in March 2016. This action is related to release mandrel breaks. The release mandrel is a component of the delivery system that is connected to the release pin which facilitates release of the valve from the delivery system.
Products manufactured after the implementation of the component change are not impacted. Boston Scientific has not received any reports of release mandrel breaks for units built after this change. There is no impact to previously implanted devices since the issue only involves the delivery system and is not related to the performance of the implanted valve. |
| Recall Action |
Recall |
| Recall Action Instructions |
Boston Scientific is advising users to immediately discontinue use of and segregate affected product. Boston Scientific will arrange for the return of affected product.
This action has been closed-out on 16/02/2017. |
| Contact Information |
02 8063 8146 – Boston Scientific QA Hotline |