Certain models of the Medtronic Paradigm insulin pump can be irrevocably damaged by exposure to MRI radiation. As a result - and based on information supplied voluntarily by Medtronic - the US Food and Drug Administration has declared a Class II recall for the affected pump models. MRIs (magnetic resonance imaging) can cause the pump to malfunction and deliver a dangerously high dosage of insulin to the user.Bottom line is that there's nothing defective about these pumps in terms of normal usage. You need only be concerned if you own one of the affected models and if your pump was exposed to MRI magnetic waves. Medtronic says the pumps that are affected should sound an alarm to warn users, but it is feared that people might override such alarms and continue using the devices, unaware that permanent damage has been done.
Owners of the affected models should have received a letter in the mail from Medtronic explaining the recall. If you use a Medtronic pump and have had an MRI, swing over to the FDA's website. There you can read the feds' statement (complete with typo misspelling "paradigm"!) on the problem and confirm whether or not yours is one of the problem pumps. This article in Diabetes Health is also useful. Strangely, I found the Medtronic website devoid of helpful info on the subject, but eventually tracked down a pdf of the letter sent to customers on the company's Canadian website.










