Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its EOPA (Elongated One-Piece Arterial) Arterial Cannula [Model Number.: 77620; Lot Number: 2015060544].
The manufacturer is initiating an Urgent Medical Device Recall for 221 units of Elongated One-Piece Arterial (EOPA) Arterial Cannula that were shipped without the guidewire. Product affected by this issue is limited to a single lot (2015060544) of model 77620. No other devices are affected by this recall. Through 29 July 2015, the manufacturer has received two field reports of this issue with no reports of adverse patient effects. In both cases, the missing guidewire was noticed prior to use. Further investigation has determined the guidewire is missing due to an isolated manufacturing error that has been addressed.
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 distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 07 August 2015