Medtronic Paradigm insulin pumps are used by diabetics to keep their insulin levels stable, but when these pumps malfunction, dangerous injuries can result. As a result, an Urgent Medical Device Recall has been issued.
What are Medtronic Paradigm Pumps?
Medtronic Paradigm insulin pumps are intended to deliver specific amounts of insulin to insulin-dependent diabetics. The insulin is dispensed from the pump’s reservoir, travels through the infusion sets and is delivered to the user via a needle inserted into the patient’s body.
The ability of this pump system to function properly depends on a component that connects the pump to the infusion sets. This “connector” contains vents that allow the air to flow through the pump system, but if the component becomes wet, liquid can clog the vents, triggering an over- or under-delivery of insulin. Depending upon the patient’s sensitivity to insulin, even a slight difference in the amount delivered can result in hyper- or hypoglycemia, leading to a number of severe side effects, including:
- Cold sweats
- Loss of consciousness
In September 2017, Medtronic announced a voluntary recall of certain lots of infusion sets used with all models of Medtronic insulin pumps connected to the over-delivery of insulin. The Paradigm insulin pumps are designed and manufactured by Medtronic MiniMed, Inc., a subsidiary of Medtronic, Inc.
Customers in the United States (U.S.) can determine if they have recalled infusion sets by visiting https://checklots.medtronicdiabetes.com.
Medtronic Paradigm Pump Lawsuits
Patients who have sustained serious injuries because of issues with Medtronic Paradigm insulin pumps may be eligible to file lawsuits to recover damages. In March 2018, a wrongful death lawsuit was filed over issues with a Medtronic MiniMed insulin pump. The device allegedly malfunctioned and pumped an entire week’s worth of insulin in a Mississippi woman in one night and she suffered a fatal stroke due to severe hypoglycemia. The device has been linked to more than a dozen deaths in recent years, according to a Minneapolis Star Tribune report.