HeartWare initiated a voluntary field correction advising healthcare professionals Feb. 7 to inspect the driveline connector housing of the HVAD pump during routine clinic visits due to a potential safety concern.
A “small number of events” (11 of approximately 2,900 implants), according to the Framingham, Mass.-based company, have been confirmed where the rear portion of the HVAD pump’s driveline connector housing becomes partially or fully separated from the front portion of the driveline connector after extended use. In the unlikely event of a separation, a repair may be necessary. If left unattended, electrical connection to the controller could be affected and a ventricular assist device stop alarm could result, HeartWare reported in a filing with the Security and Exchange Commission (SEC).
None of the confirmed events have resulted in harm to the patient, the SEC filing noted. In the event of a separation, hand tightening of the connector housing may be sufficient as a temporary measure; however, healthcare professionals are instructed to contact HeartWare to arrange for an inspection and permanent repair by a HeartWare Clinical Engineer. No product replacement or exchange is required.
As indicated in the Instructions for Use and Patient Manual, patients should not pull, kink or twist the driveline or the power cables, as these actions may damage the driveline, HeartWare noted. “Manufacturing process changes designed to prevent recurrence of this event are being implemented.”