Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its ELUVIA Drug Eluting Vascular Stent System [Material Number (UPN): H74939294601010, Batch: 25838357, GTIN: 8714729876601, Expiration Date: 31 July 2021].
The manufacturer is initiating a removal of one batch of the medical device mentioned above due to incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging. The most serious consequence would be an additional intervention to treat a lesion when a shorter than intended stent is deployed. This issue could also result in stent system exchange and prolonged procedure.
If users identify any product from the listed batch within their inventory, please segregate the product immediately and return it to the manufacturer. Users will receive replacement product for all removed product returned to the manufacturer.
According to the local supplier, the products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary action.
Posted on 23 April 2021