| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01290-1 |
| Product Name/Description |
FlexCath Advance Steerable Sheath
(Medtronic Australasia Pty Ltd - FlexCath Advance 4FC12 - Catheter introducer, haemostasis valve)
Model Number: 4FC12
All Lot Numbers
ARTG Number: 213965 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic is advising of an update to the Medtronic FlexCath Advance Steerable Sheath, Instructions for Use (IFU). This IFU revision incorporates current best practices for minimising the potential for air ingress and the risk of air embolism.
The IFU update includes additional language emphasising minimisation of catheter exchanges, proper aspiration and flushing techniques, and slow advancement and withdrawal of catheters through the sheath.
There are no changes to the management of patients who have been or will be ablated with a system using a FlexCath Advance Steerable Sheath. It continues to perform as expected in relation to the potential for haemostatic valve leak. This failure mode is monitored and the occurrence rate has been stable over time. As of 31-August-2017, 79 reports of adverse events have been reported out of more than 255,800 devices distributed worldwide. One catastrophic event, associated with death, may have been related to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtronic is providing users with a supplement the FlexCath Advance Steerable Sheath IFU to highlight the known risk of air embolism more prominently. These updates do not impact current clinical practice as this information is consistent with current training and education materials.
This action has been closed out on 19/11/2018 |
| Contact Information |
1800 929 645 - Medtronic |