| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01432-1 |
| Product Name/Description |
ARRIVE Braided Transseptal Sheath
Model Numbers: 990061-055, 990061-070, 990061-090, 990061-120, 990079-055, 990079-070, 990079-090
Multiple Lot Numbers
ARTG Number: 202067 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic was recently notified that the manufacturer, Oscor has initiated a product recall for certain lots of their Adelante Breezeway 8F & 10F sheaths due to a potential for "a fragment of the sheath inner liner to come off during the insertion of the dilator during the preparation of the sheath prior to use." Medtronic sells the Oscor Adelante Breezeway 10F product as the ARRIVE Braided Transseptal Sheath. Oscor has received one complaint related to this issue, which did not result in patient injury. However, the risk for possible injury is a concern if the sheath is not properly flushed and tested with the dilator prior to use. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to immediately quarantine and return all affected stock. Medtronic Customer Service Representative will organise the return and replacement of unused products. For affected product that has been used, no action is necessary and patients should continue to be managed in accordance with the standard patient management protocol.
This action has been closed out on 19/10/2018 |
| Contact Information |
03 8851 1020 - Medtronic |