Abiomed Recalls Some Impella Controllers Over Missed Software Updates

Abiomed has decided to initiate a voluntary medical device recall, a removal, for design changes that were previously implemented through the Abiomed field service process, according to a recall notice published by Health Canada on Oct. 2.¹

Abiomed performed a retrospective review of Field Change Notices and determined that certain Automated Impella Controllers in the field did not receive the updates introduced by Field Change Notice 113, the notice said. Not all units are affected by this issue.¹

What the defect can do

Failure to implement the applicable Field Change Notice 113 updates may result in the screen freezing during the Purge Cassette Change Wizard and the display of a false controller error, according to the notice. These defects could delay the initiation of support during device set-up and, in high-risk patient populations, may lead to temporary inadequate hemodynamic support or a temporary loss of hemodynamic support.¹

Hospital inventory may continue to be used to ensure continuity of care, the notice said.¹