Health Canada — Medical Devices · Canada · 2019-12-20 · Type II
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Reported risk: Medtronic is voluntarily issuing a safety notification related to availability of the Isomed Catheter Access Port (CAP) and refill kits. The inventory for the model 8555 refill kit, used with the Isomed pump, is expected to be depleted in the next 3-5 months. In order ensure patients implanted with a medtronic Msomed drug infusion pump can continue to receive therapy, medtronic is providing instructions for performing cap and refill procedures. Lack of ability to refill the pump or manage patient therapy due to the unavailability of accessory kits can result in sudden cessation of therapy. Sudden cessation of drug infusion therapy may result in the return of underlying symptoms and/or withdrawal symptoms, which can lead to a life-threatening condition.
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