RECALL: Medtronic Infusion Sets
Scott Benner
From Medtronic
Explanation of the Issue
Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue.
Our investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. Infusion sets currently being shipped by Medtronic contain a new and enhanced membrane material that significantly reduces this risk.
To see if your infusion sets are part of the recall please go to this page supplied by Medtronic
https://www.medtronicdiabetes.com/customer-support/product-and-service-updates/notice7-letter
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Further Press release
