Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its AngioJet Ultra Catheters. The affected devices are identified as follow:-
Boston Scientific, in cooperation with Bayer Medical Care, is initiating a recall on distributed product in the scope of a 2014 Bayer Interventional AngioJet recall. The Bayer Interventional recall was initiated due to units having incorrect 'use by' dates on the label that were one month beyond the actual use by date. The correct use by date is 2015-11 (November 30, 2015) but the date on the label is 2015-12 (December 31, 2015). The affected products are still within their valid shelf-life through November 30, 2015. No adverse health consequence is reasonably expected to result from the incorrect use by date.
The EOPA Arterial Cannula is intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration. This cannula features a dilator tip introducer to facilitate cannula insertion and priming. The introducer features a guidewire port for use with a 0.038" guidewire. As indicated in the Instructions for Use (IFU) a guidewire must be used for proper placement of the introducer tip while inserting the cannula to avoid trauma to the back wall of the aorta.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 August 2015