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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 Medtronic Australasia Pty Ltd
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