Medtronics, the maker of an insulin infusion device used with an insulin pump, has issued a voluntary recall of the Quick-set infusion sets used with MiniMed Paradigm insulin pumps because they may fail to operate properly. The recall is said to be due to a mechanical problem that could result in serious injury or death. The recall involves about 60,000 infusion sets out of an estimated three million in use according to the company.
Medtronic stated in a press release that the defect could cause the device to deliver too much or two little insulin to a patient because it could prevent air from properly venting.
The devices involved in the recall are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399. Lot number 8 is visible on the box label and on individual infusion packaging.
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Medtronic is working with the FDA to correct the problem and make product exchanges for patients involved in the recall.
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