The U.S. Food and Drug Administration (FDA) inspected our insulin infusion pump manufacturing facility and determined that our manufacturing processes are not in substantial compliance with the regulations. In the absence of compliance with these regulations, the reliability of devices cannot be assured, which could potentially result in problems with the product leading to over and/or under infusion of insulin. Health Canada has asked that we inform you of this issue. We are discontinuing the Dahedi product line and removing all of our Dahedi pumps until we have improved our manufacturing processes to adequately ensure the reliability of our pumps for their intended use. Some of the problems that have been reported include incorrect placement of the insulin cartridge, failure of the piston rod to retreat, hypoglycemic events, hyperglycemic events, and failure of the pump to respond. Note: We will be providing you with a replacement pump. Because we know how much you rely on your pump, we will allow you to continue using the Dahedi pump until you have received and been trained on your new pump. Since we are removing the Dahedi pump, we will not be performing repair work on these pumps in the future, nor will we carry any supplies specific to the Dahedi.
RecallTracker