Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning EnVeo R Loading Systems for specific lot numbers of model numbers due to particulate being observed in a small number of cases. The affected devices are identified as follows:

• Model numbers: LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C
• Lot numbers: 0007266413, 0007408862, 0007462905, 0007515698, 0007573785, 0007332504, 0007408865, 0007476215, 0007515700, 0007573788, 0007332506, 0007408867, 0007476217, 0007515703, 0007573791, 0007332508, 0007408869, 0007476219, 0007522595, 0007579940, 0007332510, 0007428258, 0007482219, 0007522598, 0007579944, 0007343321, 0007428260, 0007482222, 0007522600, 0007579948, 0007343324, 0007428263, 0007482226, 0007522603, 0007579951, 0007343327, 0007435169, 0007486826, 0007530963, 0007592664, 0007350825, 0007439358, 0007492356, 0007530973, 0007592666, 0007350837, 0007439360, 0007495691, 0007537892, 0007592669, 0007354245, 0007439362, 0007495694, 0007537894, 0007592672, 0007366949, 0007456292, 0007495696, 0007569474, 0007598984, 0007369883, 0007456298, 0007508883, 0007569477, 0007254814, 0007393098, 0007462901, 0007508885, 0007569482, 0007354113, 0007393101, 0007462903, 0007508891, 0007573778

Through 6 July 2015, the manufacturer has received eight reports related to this issue out of 7,347 potentially affected units. Two were reported as particulate being observed in packaged kits and six were reported as particulate being observed in the loading bath during valve loading.

According to the manufacturer, presence of particulate in the EnVeo R Loading System has the potential to be transferred to the Transcatheter Aortic Valve (TAV) and released into the patient's vasculature after deploying the TAV. If this were to occur, potential harms may include embolism into the bloodstream.

The manufacturer advises customers to immediately quarantine the unused potentially affected product form their inventory and return them to the manufacturer.

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 16 July 2015