Medtronic published an urgent medical device communication alerting important safety information regarding the controller driveline cover for its HVAD System.
Medtronic issued another recall of its HeartWare HVAD heart pump, this time due to problems with the driveline cover that protects the connection between the pump and the controller. Medtronic said the cover can harden over time, making it difficult to slide the cover back to fix an urgent problem with the connection or controller.
In a Nov. 29 communication to healthcare professionals, Medtronic said it has received 33 complaints about this problem as of September 22. In four of the events, patients were hospitalized to fix and remove the driveline cover, but no critical injuries or deaths were attributed to the issue, the company said.
Read the full article at Medtronic.
