Medtronic Canada Ltd., in consultation with Health Canada, is recalling select lots of Paradigm Medtronic MiniMed Insulin Reservoirs.
Medtronic is recalling the lots due to the potential risk of a leak in the reservoir that may result in under-delivery of insulin.
As well, if there is an obstruction in the infusion set, the pump alarm may not be triggered. The under-delivery of insulin may cause hyperglycaemia (high blood sugar), and in extreme cases may cause loss of consciousness or death.
The reservoirs are an alternative to injections. The pumps deliver insulin into the body throughout the day, giving patients a little more flexibility in their routine.
Doctor Arthur Kidd, an endocrinologist at Windsor Regional Hospital, says if a patient uses the device, he or she must closely monitor their condition.
He says it's important for diabetics to first learn to manage the illness the traditional way.
"If there is a problem with the pump therapy ... the patient falls back to the traditional therapy immediately to maintain their safety," Kidd said.
Medtronic Canada Ltd is notifying all customers who have purchased products from them of the recall and advising them to check their supplies to see if they have received affected lots. The lot number can be found on the side panel of the reservoir box and on the packaging of each individual reservoir.
The insulin reservoirs are used with Paradigm insulin infusion pumps, model MMT-326A and MMT-332A, manufactured by Medtronic MiniMed.
Patients who have devices from the affected lots or who are concerned about this device should contact Medtronic Canada Ltd.'s 24-hour product support line at 1-800-646-4633. Patients who have health concerns related to their use of this device should speak with their health care professional.