Medtronic Diabetes Voluntary Recall

Medtronic Diabetes is voluntarily recalling Quick-set infusion sets that have lot numbers starting with the number "8" ("Lot 8" Quick-set infusion sets). These infusion sets are used with MiniMed Paradigm insulin pumps. Considering the significance of this project, we appreciate your willingness to work with us in assisting our recall process for the benefit of your members.

Very recently, it has come to our attention that certain insurance companies and/or providers are recommending that members switch to competitor infusion sets and/or insulin reservoirs in response to this recall. While this is ultimately a patient's choice, we believe this unnecessary based on our plan for adequately providing replacement Medtronic infusion sets to your members and ensure continuity of pump therapy.

Perhaps more important, using non-Metronic products with a Medtronic pump will void the Medtronic pump warranty if any damage is caused by the non-Medtronic products. Moreover, should any damage occur, patients may be without their insulin pumps for a length of time (if they do not have a back-up pump). The specific Medtronic warranty language is as follows:

"This warranty is valid only if the Medtronic MiniMed Insulin Pump is used in accordance with the manufacturer's instructions. This warranty will not apply if damage results from use of non-Medtronic reservoirs and/or infusion sets."

We of course have a direct interest in continuing to serve patients with our own products. We believe, however, that these warranty issues may be important factors for patients considering competitor supplies. As you would agree, patients should be fully informed before making decisions about their therapy. Therefore, to the extent relevant and/or necessary, we strongly encourage you to communicate this warranty issue to members as applicable.

As we stated before, we are taking this recall action voluntarily to ensure the safety of our patients (and your members). We are doing all that we can to make this process as timely and as easy as possible and, as mentioned, ensure continuity of care for all affected patients.