Product and Service Update

Product and Service Updates

At Medtronic, customer safety is our top priority. Occasionally, new information regarding the safe and proper use of our products and services comes to light. We’re committed to helping our customers and their health care professionals stay informed with our medical device safety updates.

important medical device safety information


Medtronic MiniMed Infusion Sets - Potential over-delivery of insulin

Because the safety of our customers is our top priority, we are voluntarily recalling specific lots of infusion sets used with Medtronic insulin pumps. 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.

New Look for Infusion Set and Reservoir Boxes

We are excited to inform you that we are updating the look for our infusion set and reservoir boxes. We hope this will improve your experience by creating a clean, modern and uniform look for our infusion sets and reservoirs boxes. In addition, we have made it easier to identify the days of use reminder for proper infusion set and reservoir wear.

Medtronic Paradigm® reservoir recall

With safety as our top concern, we would like to make you aware that we are recalling certain manufacturing lots of Paradigm reservoirs that may have an increased potential for leaking. A leak in the reservoir may result in delivery of less insulin than intended, and if there is an insulin blockage in the infusion set, the pump may not alarm.

Medtronic Paradigm® tubing connectors

While changing an infusion set, if insulin, or any liquid, gets on the inside of the tubing connector on Paradigm infusion sets, it can temporarily block the vents that allow the pump to properly prime. We are discussing this issue with our customers because it can potentially result in too much or too little insulin being delivered, which may cause hypoglycemia or hyperglycemia.

Potential loose drive support cap and water damage

At Medtronic, we’re committed to keeping our customers informed of issues and solutions concerning our products and services. That is why we’re notifying all global Paradigm customers and healthcare professionals to advise them of a potential safety issue that has been identified.