| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00194-2 |
| Product Name/Description |
MindFrame Capture LP
All Models Affected (unexpired product numbers: 300010, 300011, 300012, 300013,300014, 300015, 300016, 300017, 300018)
All Lot Numbers Affected.
ARTG Number: 283135
(Medtronic Australasia - Mindframe Capture LP Revascularization Device - Embolectomy/thrombectomy suction catheter) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified the potential for an issue with all MindFrame Capture LP devices to partially detach or separate from the delivery wire. |
| Recall Action |
Recall |
| Recall Action Instructions |
For affected product that has not been used, Medtronic is advising users to quarantine all unused affected product to prevent further use and return them. A Medtronic representative can assist in facilitating the return of product as necessary.
Medtronic is providing surgeons with the following patient management recommendations in the event they have experiences a partial or full separation of the MindFrame Capture LP device during a procedure resulting in the device or device fragments being retained in the patient:
· Consider anti-platelet therapy if clinically indicated, at the provider’s clinical discretion.
· Consider close physician follow-up with the patient and repeat imaging if clinically indicated, at the provider’s clinical discretion.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 9857 9000 - Customer Service Support |