| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01107-1 |
| Product Name/Description |
Solitaire Platinum Revascularisation Device
Product Codes: SRD3-4-20-10, SRD3-4- 40-10, SRD3-6-20-10 and SRD3-6-40-10
ARTG Number: 284964 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
23/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic is advising that the Instructions for Use (IFU) included with Solitaire Platinum Revascularisation Devices supplied to date do not have correct information regarding Indication for Use in Australia as approved by the TGA:
The Solitaire Platinum Revascularisation Device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset; and the device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t- PA therapy are candidates for treatment. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Refer to the Instructions for Use included with the customer letter. Continued use of the Solitaire Platinum product as per the TGA approved indication for use is permissible.
Complete the Customer Confirmation form supplied with the customer letter and fax it to Medtronic.
Share this notification and the included Instructions for Use with others as appropriate, and contact Medtronic Territory Managers with any questions related to this product recall.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 668 670 - Medtronic |