Health Canada — Medical Devices · Canada · 2021-08-27 · Type II
As described by Health Canada — Medical Devices: Medtronic HeartWare Ventricular Assist Device (HVAD) System/licence (2021-08-11)
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Reported risk: Notification related to HVAD Systems that have undergone a Driveline Strain Relief Repair performed by a Medtronic Field Service Representative. Medtronic internal testing has shown that it may be difficult to pull back the Driveline Cover over a Strain Relief Repair when attempting to access the Driveline Connector. Difficulty in pulling back the Driveline Cover over a Strain Relief repair may cause a delay in accessing the Driveline Connector. This delay may lead to a prolonged pump stop if access to the Driveline Connector is required to address a marginal Driveline connection or change controllers. In addition, pulling back the Driveline Cover over a Driveline Strain Relief Repair may compromise the integrity of the repair. In lab testing, the most common issue observed was the tape that overlaps the end of the Driveline Connector rolled back when pulling the Driveline Cover away from the controller.
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