Medical device manufacturer, Biotronik, has issued a medical device safety alert concerning its Orsiro Sirolimus Eluting Coronary Stent System [Reference numbers: 391240 & 391241; Lot numbers: 02152670, 02152671, 02152672, 02152673].
According to the manufacturer, four lots of the Orsiro stent system had been wrongly labeled. The labeled diameter does not reflect the actual diameter of the packed product.
The use of a product from the affected lots may result in vessel injury and/or increased procedure time. Users are advised to discontinue any further use of the affected products.
According to the local supplier, only one lot [Reference number: 391241 and Lot number: 02152673] of the affected products had been imported and distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 June 2015