Sorin Perceval S Post-Dilation Catheter Size M (indicated for in situ post-dilation of the valve after implantation) 의 리콜

Recall

RC-2014-RN-00032-1

Class I

2014-01-20

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00032-1

For the size and lots identified, the blue marker (placed on the catheter shaft close to the balloon proximal extremity, aiding correct positioning of the balloon with respect to the prosthesis, prior to dilation) may detach and displace during removal of the plastic tube which protects the balloon. removal of the plastic tube protection may displace the blue marker distal to the balloon. if this is not identified, the blue marker might then fall in the operative field, including the possibility to fall in the patient ventricle during the post-dilation procedure, causing serious injury or death if it is not retrieved.

Sorin is recommending that clinicians follow the indications provided in the customer letter to remove the plastic tube protecting the balloon and to verify that the blue marker is not displaced. In case the verification leads to the conclusion that the marker is displaced, the involved post-dilation catheter must not be used and must be replaced with a new one.