ARROW Intra-Aortic Balloon Catheter and Percutaneous Insertion Kits 의 리콜

Recall

RC-2016-RN-00204-1

Class I

2016-02-24

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00204-1

The arrow intra-aortic balloon catheter and percutaneous insertion kits contain a percutaneous sheath introducer. the percutaneous sheath introducer is used by some clinicians in the intra-aortic balloon catheter insertion procedure. the manufacturer has advised there is the possibility that the percutaneous sheath introducer body may become separated from the sheath hub. if the separation occurs, there is a potential for bleeding from the device. if bleeding is not addressed with prompt intervention, it may result in loss of significant blood volume or exsanguination. in addition, delay of treatment, interruption of treatment, or loss of iab therapy can occur.

The sponsor is advising customers to immediately quarantine all affected kits. The sponsor will deliver replacement kits to the affected customers before the recovery of the affected kit. In the case of an emergency situation before the replacement kit can be delivered, the sponsor is advising that the Arrow IntraAortic Balloon Catheter can be inserted through the following alternative 8 Fr. sheaths: -St Jude Medical Diag Maximum -Terumo Pinnacle -Cordis Avanti . This action has been closed-out on 23/05/2017.