Medtronic MiniMed Paradigm insulin infusion sets: Class 1 recall due to potential for over or under delivery of insulin


Intravenous products: FDA report “On June 7, 2013, Medtronic sent an urgent medical device safety notification to healthcare professionals to inform them of the potential for over or under delivery of insulin if insulin or other fluids contact the inside of Medtronic Paradigm Tubing Connectors. On June 10, 2013 Medtronic sent an Urgent Medical Device Safety Notification to all Paradigm Insulin pump users and distributors to inform them of this issue. If insulin or other fluids come in contact with the inside of the tubing connector it can temporarily block the vents that allow the pump to properly prime. This can result in too much or too little insulin being delivered, resulting in hypoglycemia or hyperglycemia, which can be severe and lead to serious illness.”

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