Medtronic MiniMed Paradigm Quick-Set (Infusion Sets) Recall

I know I’m a little behind the news flash on this one, but I want to make sure that all my readers know about this recall. Medtronic announced a voluntary product recall for all of the Paradigm Quick Set (mostly in U.S.) infusion sets that have a reference number of MMT-396 to MMT-399 along with a lot number starting with an 8. I checked the 5 boxes I had on hand and every one of them are part of the recall. Here is part of the press release from Medtronic.

Medtronic, Inc. (NYSE:MDT) said today that it has initiated a recall of specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8.” Medtronic recently discovered that approximately two percent of “Lot 8” Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work properly. The affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death.”

Click here to access Medtronic’s web page regarding the recall with instructions on what to do. It got a little fuzzy when I tried to figure out how to exchange my sets for new ones. I called my supplier and they said I should be receiving something from Medtronic or getting a call back from them with further instructions. It seems that Medtronic is pointing to the suppliers and the supplier is saying they are awaiting more instructions from Medtronic.

Author: Andrew S. Hostetler

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