Recall: Medtronic MiniMed Paradigm Insulin Infusion Sets, Potential for Wrong Dose

July 26, 2013 | Strategic Insights for Ambulatory Care


The U.S. Food and Drug Administration (FDA) has warned clinicians about a known problem with infusion sets used with MiniMed Paradigm insulin infusion pumps that may cause them to over- or under-deliver insulin if insulin or other fluids contact the inside of the tubing connector. The pumps and infusion sets are manufactured by Medtronic Inc. (Minneapolis, Minnesota). Affected products were distributed between December 2001 and June 2013 and are listed in an FDA recall notice.

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