| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00713-1 |
| Product Name/Description |
PROMUS Element Plus MONORAIL Everolimus-Eluting Coronary Stent System
Multiple lot numbers affected
ARTG Number: 200539 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
Units of the PROMUS Element Plus MONORAIL Everolimus-Eluting Coronary Stent System has been supplied without the appropriate Australian Directions For Use (DFU) ie, the appropriate content of the pre- and post- procedure anti-platelet regimen is not included in the DFU. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Boston Scientific is undertaking a recall for product correction to provide a copy of the correct DFU for end users to follow. Surgeons who have implanted an affected batch of the device are being provided with a Hazard Alert letter with the information on the correct post-procedure anti-platelet regimen. |
| Contact Information |
02 8063 8340 - Boston Scientific Quality Assurance |