Certain Medtronic Infusion Sets Used with Paradigm Diabetes Pumps Linked to Over- or Under-Delivery of Insulin

Posted on 11/14/2017Back

On September 11, 2017, Medtronic announced a recall of “specific lots of infusion sets used with all models of Medtronic insulin pumps.” The recall notice specifically identifies a vent in a piece that connects infusion sets to the pump’s reservoir as the source of the problem and indicates that infusion sets sold prior to April 2017 may have contained this component. Patients with recalled infusion sets should immediately discontinue using them, as the blocked vent may result in serious injuries.

What are Infusion Sets?

An infusion set serves as a delivery system for insulin from a diabetes pump to a patient. The infusion set connects to an insulin pump on one side and to a small needle, housed in a cannula, which is inserted into a patient’s body.

What’s the Problem?

To function properly, the pump system is equipped with a piece that connects the infusion sets to the pump’s reservoir. This connector contains vents which allow air to flow through the pump’s reservoir. However, if the component becomes wet, liquid (including water and insulin) can clog the vents, triggering an over- or under-delivery of insulin to the user. Depending upon a patient’s sensitivity to insulin, even a small difference in the amount being delivered can have a catastrophic impact.  The under- or over-delivery of insulin can cause hyper- or hypoglycemia, resulting in loss of consciousness, serious injuries, and death.

GoldenbergLaw Can Help

GoldenbergLaw is actively litigating these cases. Please contact Partner Marlene Goldenberg to discuss referral opportunities.

Category Defective Medical Devices