Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its implantable defibrillators, Autogen and Dynagen. [Model: i) Model G150 Dynagen CRT-D; ii) Model D020 Dynagen Mini ICD; iii) Model G172 Autogen CRT-D; iv) Model D044 Autogen Mini ICD. Serial numbers: i) SN100195, SN100153; ii) SN100079, SN100121; iii) SN100476, SN100550; iv) SN100197, SN100292].
The manufacturer forwarded eight devices to Avalon Medical International S.A. for product registration purposed in Venezuela. These devices were labelled "Not For Human Use". The manufacturer learned both through a Venezuelan doctor and the sub-distributor in Venezuela that four of the devices were implanted in patients in Venezuela. The manufacturer later determined that the implanted devices are in fact suitable for use in humans. The manufacturer requires all affected users and distributors to establish mechanisms to prevent the above-mentioned situation from happening again.
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 03 June 2015