Medtronic recently gained FDA approval for its CoreValve Evolut R valve. Now a delivery device related to the product is the subject of an FDA Class 1 Recall.
Background
The newly announced FDA Class 1 Recall applies to the EnVeo™ R loading system for Medtronic’s CoreValve Evolut transcatheter aortic valve device. The recall pertains to specific lot numbers and relates to particulates being observed in a small number of cases. Medtronic has received reportedly eight reports related to this issue out of 7347 potentially affected units. Two were reported as particulate matter being observed in packaged kits and six were reported as particulate being observed in the loading bath during valve loading. To date, there have been no reports of any adverse patient effects with this issue, which FDA says involves 6912 units in commerce, 540 of which were being used in clinical trials in the United States. This issue does not affect other Medtronic devices or other components of the Evolut® R TAVI system. Find the Recall Notice here. Source: FDA